chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: shots make me sick; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced shots make me sick (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number 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 shots make me sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  It was reported "the shots make me sick, so I won't get them".  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu in the last 20 years was the one time I got conned into taking it; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious social media from a consumer/non-healthcare professional.  This case involves adult patient of unknown gender who "had the flu in the last 20 years was the one time I got conned into taking it" (influenza), 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 "had the flu in the last 20 years was the one time I  got conned into taking it" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "this social media case was received. Since this is a public post on the flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the flu vaccine. Author/Reporter Comment: only time I have had the flu in the last 20 years was the ONE time I got conned into taking it 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 reported event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: very ill; Initial information received on 06-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves an unknown demographic patient who experienced very ill (illness) 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 very ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Flu Shot Fridays the only and ONLY time I ever got the flu jab was around 15 years ago. I became very ill, I think I am all set. P.s. the numbers for flu cases were down to nearly 0 last year across the country. Everything but c 19 just disappeared."  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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown gender child patient who experienced flu (influenza) 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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Did as an elementary kid and have never taken the shot as an adult! I got deathly sick as a kid with flu more than once have never contracted it as an adult!!!!"  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.
Sex: U
Vaccine: FLUX
Symptoms: Bedridden, Illness
Clinical narrative: was in bed almost 2 weeks, almost died; sick; Initial information was received on 06-Oct-2021 regarding an unsolicited valid Social Media serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who was in bed almost 2 weeks, almost died (bedridden) and 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 medications 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 not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was in bed almost 2 weeks, almost died (bedridden) and sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. These events were leading to disability.  Aspirin, Vitamin C, and some good Chicken Soup is all that patient needed  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 of events was unknown.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a patient (age unspecified) had illness and was bedridden after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and 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: Influenza
Clinical narrative: It gave flu to patient; Initial information received on 06-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.   This case involves adult and unknown gender patient who it was reported it gave me flu (influenza) while receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease, or risk factor. 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 dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient developed a non-serious event it gave flu to patient (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "last flu shot I got two years ago, gave me the flu, so will never take another one. If I go out I wear a mask anyway. I'm tired of being told what to do".  There were no lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received ant 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: Asthma, Condition aggravated, Impaired work ability, Influenza, Loss of consciousness
Clinical narrative: Patient got vaccinated but got the flu only time he/she ever passed out in his/her life; with asthma patient's symptoms were fairly tough; was out of work for a week; Patient got vaccinated but got the flu; Initial information received on 06-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consume (under reference US-SA-SAC20211011000354).  This case involves an adult patient with unknown gender who experienced serious event patient got vaccinated but got the flu only time he/she ever passed out in his/her life (loss of consciousness), with asthma patient's symptoms were fairly tough (asthma), patient got vaccinated but got the flu (influenza)  and was out of work for a week(impaired work ability) while receiving INFLUENZA VACCINE.  The patient's past medical treatments, concomitant medications, vaccinations and family history were not provided.  At the time of the event, the patient had ongoing Asthma.   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 serious event patient got vaccinated but got the flu only time he/she ever passed out in his/her life (loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date the patient developed non-serious events with asthma patient's symptoms were fairly tough (asthma), patient got vaccinated but got the flu (influenza) and was out of work for a week(impaired work ability) (unknown latency) following the administration of INFLUENZA VACCINE. The patient reported that four years ago, he/she got vaccinated but got the flu the only time he/she ever passed out in his/her life and with asthma his/her symptoms got tougher and was not able to work for a week. The patient also mentioned that with vaccine protection he/she would not be alive till date.  It was 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 events.  At time of reporting, the outcome of events was reported as unknown.; Sender's Comments: This case involves an adult patient with unknown gender who experienced a serious event loss of consciousness and non serious events asthma, influenza and impaired work ability after receiving INFLUENZA VACCINE (unknown manufacturer). The patient had ongoing Asthma. The time to onset is unknown for the events. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed
Sex: U
Vaccine: FLUX
Symptoms: Dysgeusia, Illness
Clinical narrative: For months all I could taste was metal; I was never so sick in my life; Initial information received on 07-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who experienced "for months all i could taste was metal" (dysgeusia) and "i was never so sick in my life" (illness) while receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious "for months all i could taste was metal" (dysgeusia) and "i was never so sick in my life" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "last time I got one because my doctor told me I'm old and need one. I was never so sick in my life. For months all I could taste was metal. Doctor said don't get it again. Haven't been sick since".   Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  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.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: I am allergic to it; Initial information was received on 07-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care via Social Media.  This case involves a patient of unknown age and gender who had allergic to vaccine (allergy to vaccine), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious allergic to vaccine (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Bone pain, Feeling abnormal, Feeling cold, Tremor
Clinical narrative: freezing shaking every bone in body ache today I feel like crap; freezing shaking every bone in body ache today I feel like crap; Initial information was received on 06-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer (under reference number: US-SA-SAC20211011000731).  This case involves an adult patient with an unknown gender who experienced non serious events "freezing shaking every bone in body ache today I feel like crap" (tremor) and "freezing shaking every bone in body ache today I feel like crap" (bone pain) while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   The patient had no 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 non-serious events "freezing shaking every bone in body ache today I feel like crap" (tremor) (unknown latency) and "freezing shaking every bone in body ache today I feel like crap" (bone pain) following the administration of INFLUENZA VACCINE.  It was reported "Got my shot yesterday and boy did it hit me last nite freezing shaking every bone in body ache today I feel like crap. This has never happened to me."  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 events   At time of reporting, the outcome of events was reported as unknown.  There will be no information on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Mobility decreased
Clinical narrative: so sick, ended up in bed for almost 2 weeks; Initial information was received on 06-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-SAC20211011000847).  This case involves a patient of (unknown demographics) who experienced so sick, ended up in bed for almost 2 weeks (illness), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  Concomitant medications included ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) for Cold; and GUAIFENESIN (GUAIFENESINE) for Cold.  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 so sick, ended up in bed for almost 2 weeks (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "it made me so sick I ended up in bed for almost 2 weeks. Damn near died from it.NEVER AGAIN! I deal with colds and flu with guiafenesin, aspirin, and chicken soup.and am doing fine with that."  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: DTAPIPVHIB
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: PENTACEL was given incorrectly because at the end of the yesterday she found the powder portion and not the liquid portion with no adverse event; Initial information was received on 07-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves adult patient (unknown age and unknown gender) who received powder portion not liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to product preparation issue (latency: same day).  At time of reporting, no adverse event reported.   It was reported "PENTACEL was given incorrectly because at the end of the yesterday she found the powder portion and not the liquid portion so she assumes the patient did not get the powder portion with the liquid portion."  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 lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: got a Half a dozen last week, with no adverse event; Initial information received on 08-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.   This case involves adult and unknown gender patient who got a half a dozen last week (extra dose administered) while receiving INFLUENZA VACCINE.  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 dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [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 extra dose administered [Latency: on the same day].   Details of laboratory data not reported.  At the time of report no adverse event was 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.   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. 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: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm is sore; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Agency (under reference number - US-SA-SAC20211011001392).  This case involves adult patient of unknown age and gender patient who experienced arm is sore (pain in extremity), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, 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.  On an unknown date, the patient developed a non-serious arm is sore (pain in extremity) (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: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: Sore arm; Initial information was received on 07-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 and unknown gender patient who experienced sore arm (pain in extremity) while receiving INFLUENZA VACCINE and COVID-19 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 in last week, the patient received booster dose of suspect COVID-19 VACCINE not produced (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 06-Oct-2021 (yesterday), 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 sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: Almost died; Initial information was received on 09-Oct-2020 regarding an unsolicited non-valid non-serious case received from a consumer or non-healthcare professional (patient) via public post on the flu shot campaign.  This was an non-valid case as adverse event not specified.  This case involves patient who after receiving flu shot was almost died, while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications 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 adverse event as after flu shot patient was almost died (unevaluable event) on an unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the unevaluable event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu both times; Initial information received on 09-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional..  This case involves adult patient (unknown age and gender) who experienced flu both times (influenza), while receiving vaccine INFLUENZA VACCINE.  The patient had no 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 two doses 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 both times (influenza) (unknown latency) following the administration two doses of INFLUENZA VACCINE.  It was reported "I have had the flu shot twice and got the flu both times. No amount of convincing will get me to take it again".  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 unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: Got mine in August and in the hospital with pneumonia; flu; Initial information received on 09-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer (under reference number: US-SA-SAC20211012000320).  This case involves a patient with an unknown demographics who experienced serious events got mine in August and in the hospital with pneumonia (pneumonia) and 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, in the month of August, 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 serious events got mine in august and in the hospital with pneumonia (pneumonia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  On an unknown date, the patient developed a serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  It was unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  An unknown corrective treatment was received for the events.  At time of reporting, the outcome of events was reported as unknown.  It was unknown if patient's physician provided consent to be contacted.; Sender's Comments: This case involves a patient with an unknown demographics who experienced serious events pneumonia and influenza (unknown latency) after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown with the role of the vaccine. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: slight sore arm; Initial information received on 09-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who experienced slight 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'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 non-serious slight sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got mine yesterday. Love the expression Flu shot Friday. Not a regular for flu vaccine, but feel this is the time to start. Just a slight sore arm".   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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Fatigue, Pain in extremity
Clinical narrative: little fatigue; sore arms; Initial information was received on 07-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a (unknown demographic) patient who experienced little fatigue (fatigue) and sore arms (pain in extremity) when received vaccine INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, 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 (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 little fatigue (fatigue) and sore arms (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I initially went in to get my flu shot and to schedule my booster shot for the following week. My pharmacist said I could get both at the same time so I went for it. Other than a little fatigue and sore arms, I was fine."  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 events.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 09-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional..  This case involves adult patient of unknown gender who had flu (influenza), 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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "the following potential adverse event has been found on a public post on a social media page. I took flu shots twice and both times ended up with the flu! When I started taking Vitamin D3, I stopped getting colds and flus!"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available  The patient was treated with VITAMIN D3 for Influenza.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: all over body pain; fatigue; injection site is very painful; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 65-year-old male patient who had all over body pain (pain), fatigue and injection site is very painful (vaccination site pain), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  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 07-Oct-2021, the patient received a dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once, injection, lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 08-Oct-2021, the patient developed non-serious all over body pain (pain), fatigue and injection site is very painful (vaccination site pain) (one day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "next day after receiving shot woke up with all over body pain and fatigue. Also, injection site is very painful. Could not sleep on the arm."  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.  At time of this report, the patient was recovering from all the reported events.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Localised infection
Clinical narrative: arm got infected; Initial information received on 07-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (unknown age and gender) who had arm infected (localised infection) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received 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's arm got infected (localised infection, non-serious) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  It was reported "Got my flu shot last year arm got infected had to take antibiotics for seven days no thanks I will pass."  It was reported that the patient received antibiotics for a seven days as corrective treatment.  At time of reporting, the outcome was unknown for the reported event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 08-Oct-2021 regarding an unsolicited valid serious case received from social media from consumer/non-health care professional via regulatory authority (under reference number - US-SA-SAC20211012000839).  This case involves adult patient of unknown age and gender patient who experienced flu (influenza), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, 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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  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 adult patient of unknown age and gender patient who experienced flu (influenza), after vaccination with INFLUENZA VACCINE. The time to onset is compatible with the role of the vaccine. However, patient's medical condition at time of vaccination, Lab data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the individual vaccines cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Influenza like illness, Rhinorrhoea
Clinical narrative: flu like symptoms; runny nose; cough; Initial information received on 10-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer Non-Healthcare Professional (under reference number: US-SA-SAC20211012001046).  This case involves Adult female patient who was experienced flu like symptoms, runny nose and cough (influenza like illness and rhinorrhoea) while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported.  On an unknown date the patient developed a non-serious events flu like symptoms, runny nose and cough (influenza like illness and rhinorrhoea) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/ event.  It is unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment from the events.  At time of reporting, the patient outcome was Unknown for the events.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: it makes me sick; Initial information was received on 09-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves adult patient of unknown gender who had "it makes me sick" (illness), 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 "it makes me sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "the following potential adverse event has been found on a public post on a social media page. I cannot take the flu shot it makes me sick but I did get my 2 (Corona Virus Disease) COVID shots."  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 event.  At time of this report, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was inadvertently administered the Fluzone High-Dose Quadrivalent vaccine, rather than the Fluzone Quadrivalent vaccine with no reported adverse event; FLUZONE HIGH DOSE QUADRIVALENT was given to a consumer under 65, with no adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via agency (under reference- 00791171 ).  This case is linked to case 2021SA326103 (CLUSTER).  This case involves a 19 years old female patient who was inadvertently administered the QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), rather than the QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) [wrong product administered and product administered to patient of inappropriate age].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ733AA, expiry date-30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to wrong product administered and product administered to patient of inappropriate age. (latency: same day).  It was reported "HCP (Healthcare Professional) stated FLUZONE HIGH DOSE QUADRIVALENT was given to a consumer under 65 and wanted to know if there was any data? Pharmacist stated that two patients under age 65 had inadvertently been administered the Fluzone High-Dose Quadrivalent vaccine".  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.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue, Underdose
Clinical narrative: just the liquid vial (DTaP-IPV component) was given to the patient and it was not mixed with the powder (Hib component), with no reported adverse event; just the liquid vial (DTaP-IPV component) was given to the patient and it was not mixed with the powder (Hib component), with no reported adverse event;Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a nurse and consumer/ non-healthcare professional via Media Information (under reference 00794305).  This case involves a 2 months old female patient who just received the liquid vial (dtap-ipv component) and it was not mixed with the powder (hib component) of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] [product preparation issue][vaccine underdose].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 30-Sep-2021, the patient received a first dose of suspect PENTACEL (VERO) [Total, lot number for Powder vial (Hib component): UJ425AA, lot number for Liquid vial (DTaP-IPV component): U6899AA and expiration date: 21-May-2022] via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to Inappropriate reconstitution technique and vaccine underdose(same day latency).  It was reported "Nurse states that she has questions about PENTACEL if only half was given. Nurse states that just the liquid vial (DTaP-IPV component) was given to the patient and it was not mixed with the powder (Hib component). Nurse asking if she should give the shot again after mixing it or if she should just give a Hib."  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.