chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: took one flu shot and it almost killed me, five weeks and I've never been sick in my life; Initial information was received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer via social media (under reference number: US-SA-SAC20211006000097).  This case involves an unknown gender adult patient who experienced a non-serious event took one flu shot and it almost killed me, five weeks and I had never been sick in my life (malaise) while receiving vaccine 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 event took one flu shot and it almost killed me, five weeks and I had never been sick in my life (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  On an unknown date, at time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 03-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 demographics patient who experienced flu (influenza) after receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  There were no lab data/results available.  It was reported "I've had the flu jab because of my work for the past 20 years. In July this year I got the flu."  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Sleep disorder
Clinical narrative: had interrupted sleep the entire time; got a sore throat; bad cold; congestion; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional via social media.  This case involves patient (Adult and unknown gender) who had interrupted sleep the entire time (sleep disorder), got a sore throat (oropharyngeal pain), bad cold(nasopharyngitis) and congestion (nasal congestion) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included COVID-19 VACCINE for Immunisation.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not provided) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "had interrupted sleep the entire time" (sleep disorder), got a sore throat (oropharyngeal pain), bad cold(nasopharyngitis) and congestion (nasal congestion) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "Got my flu shot September 22, got a sore throat the following Friday which turned into a bad cold & congestion which i still have to this day. I've had interrupted sleep the entire time. I had flu shots for 25 years & never had this problem. Yes, I've had both Covid shots earlier this year."  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Decreased immune responsiveness
Clinical narrative: reduced immunity by 30% towards other viruses.; Initial information was received on 03-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient of (unknown demographics) who was experienced reduced immunity by 30% towards other viruses (decreased immune responsiveness), 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 reduced immunity by 30% towards other viruses (decreased immune responsiveness) (unknown latency) following the administration of INFLUENZA VACCINE.  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: got guillain barre syndrome from a flu shot; Initial information received on 30-Sep-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional. This case is linked to cases 2021SA330955(CLUSTER) and 2021SA330928(CLUSTER).  This case involves Adult male patient who had got guillain barre syndrome from a flu (guillain-barre syndrome) shot after receiving INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was unknown if the patient had any 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 developed a serious got guillain barre syndrome from a flu shot (guillain-barre syndrome) (unknown latency) following the administration of vaccine. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  There will be no information on the batch number for this case.  It was not reported if the patient received a corrective treatment for the event (got guillain barre syndrome from a flu shot).  At time of reporting, the outcome was Unknown for the event got guillain barre syndrome from a flu shot.; Sender's Comments: This case concerns an Adult male patient who had guillain-barre syndrome after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is compatible. However, patient's medical condition at the time of vaccination and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Wrong product administered
Clinical narrative: went in for a flu shot, gave her Covid vaccine by mistake; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-hcp (health care professional ).  This case involves an unknown age female patient who went in for a INFLUENZA VACCINE shot, but received her COVID-19 (corona virus disease) VACCINE by mistake (wrong product administered) and died shortly after on an unknown date.  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 COVID-19 VACCINE not produced by Sanofi Pasteur instead of INFLUENZA VACCINE (unspecified manufacturer) (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered (same day latency).  It was reported "it is happening. Just heard yesterday about a lady who went in for a flu shot, gave her Covid vaccine by "mistake" Told her mistakes happen. She died shortly after."  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  At time of reporting, the outcome unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: mild cold; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non- health care professional.  This case involves patient of unknown demographic who experienced mild cold (nasopharyngitis) after receiving INFLUENZA VACCINE.  The patient past vaccination(s) included INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease, or risk factor.  The patient medical history, medical treatment(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 cold (nasopharyngitis) (severity: mild) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, I've been getting a flu shot every year and haven't been sick for almost 5 years now other than a mild cold .Now I've got both poison shots, so I don't think I'm going to mix the flu shot with it for a while".   There were no lab data/results available.  It was not reported if the patient received any corrective treatment for the event (mild cold).  At time of reporting, the outcome was unknown for the event mild cold.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Wrong product administered
Clinical narrative: Patient hope a Covid shot wasn't given by mistake with no AE; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.   This case involves patient of unknown demographic for whom it was reported "hope a covid shot (COVID-19 VACCINE) wasn't given by mistake" while receiving INFLUENZA VACCINE (Wrong product administered).  It was unknown if the patient had any medical history, concomitant disease, or risk factor.  The patient 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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur [lot number and expiry date not reported] via 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].    There were no lab data/results available  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  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.
Age: 6.0
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Wrong product administered
Clinical narrative: they was suppose to be giving the flu shop and (say) they accidently gave it the covid shot, with no reported AE; Initial information was received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer (under reference number: US-SA-SAC20211006000416).  This case involves an unknown gender 6-years old patient who accidently received COVID-19 VACCINE instead of INFLUENZA VACCINE. (wrong product administered)  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 COVID-19 VACCINE not produced by Sanofi Pasteur lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered (same day latency).  It was reported "like that little 6-year-old they were supposed to be giving the flu shop and (say) they accidently gave it the COVID shot. what made us trust them to not massively do it to thousands of people."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  At the time of reporting, no adverse event reported.  There will be no information on lot number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non- health care professional.  This case involves an unknown age and unknown gender patient who experienced flu (influenza) while receiving INFLUENZA VACCINE.  The patient past vaccination(s) included INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient, medical treatment(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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I took my vitamins and brushed my teeth today. I haven't had a flu shot in about 40 years. Last time I had the flu was 17 years ago, and no idea how long ago before that one. I know people that get the flu shot every year, then get the flu that same year. Every year same conversation. I don't understand it. I got the flu shot, but I still got the flu.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment for the event (flu).  At time of reporting, the outcome was unknown for the event flu.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; Initial information was received on 30-Sep-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case is linked to cases US-SA-2021SA330912(CLUSTER) and US-SA-2021SA330928(CLUSTER).  This case involves a (unknown age) female patient who experienced stroke (cerebrovascular accident) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations 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 stroke (cerebrovascular accident) (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.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event stroke.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a (unknown age) female patient who experienced cerebrovascular accident (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: Limb discomfort
Clinical narrative: Suffering from the results, especially in the Left leg; Initial information was received on 03-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient of (unknown demographics) who was experienced suffering from the results, especially in the left leg (limb discomfort), 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 non-serious suffering from the results, especially in the left leg (limb discomfort) (unknown latency) following the administration of INFLUENZA VACCINE.  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: little soreness in arm; Initial information regarding an unsolicited valid non-serious case was received from Pfizer (non-licensed partner) (MFR Control No: 202101287785) in the form of courtesy via a consumer/non-healthcare professional and transmitted to Sanofi on 30-Sep-2021.  This case involves a 69-year-old female patient (165 cm and 94 kg) who experienced little soreness in arm (pain in extremity) while received INFLUENZA VACCINE, MODERNA COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.  The patient's past medical treatments, vaccinations and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Concomitant medications included RIVAROXABAN (XARELTO).  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 a right arm for prophylactic vaccination.  On 29-Jan-2021, the patient received a dose of suspect PFIZER BIONTECH COVID-19 VACCINE not produced by Sanofi Pasteur (lot number: EN3318 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 20-Feb-2021, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by Sanofi Pasteur (lot number: EL9267 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 28-SEP-2021 the patient developed a non-serious little soreness in arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, 8 months following the administration of PFIZER BIONTECH COVID-19 VACCINE and 7 months 8 days following the administration of MODERNA COVID-19 VACCINE.  It was reported "Caller reporting that she received both doses of Pfizer BioNTech Covid19 vaccine and when she got booster it was Moderna vaccine. She wants to make sure it is ok and that she will be covered. Will the immunity be effective?"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  Advil as a corrective treatment was received for the event.  At time of reporting, the outcome was unknown for the event little soreness in arm.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: patient was given a covid vaccine instead of the regular flu vaccine, with no reported adverse event; Initial information was received on 03-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  The case is linked to case 2021SA331684 (cluster).  This case involves female patient (unknown age) who was given a coronavirus disease (COVID-19) VACCINE instead of the regular INFLUENZA VACCINE (wrong product administered).  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 COVID-19 VACCINE (not produced by Sanofi Pasteur) instead of 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.  It was an actual case of medication error due to wrong vaccine administered (same day latency).  It was reported "They have and gave a 4 year old the covid vaccine adult dosage supposed by mistake and a lady was given a covid vaccine instead of the regular flu vaccine."  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  At 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 lot number for this case.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired vaccine/ no AE; Initial information was received on 24-Sep-2021 regarding an unsolicited valid non-serious case from an other health professional.  This case involves four patients who received expired vaccine IPV (VERO) [IPOL] (expired product administered).  The patients' past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patients had any medical history, concomitant disease or risk factor.  On an unknown date, the four patients received a dose of suspect IPV (VERO) (lot number: J1406 and expiry date: 28-Mar-2015) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was unknown if the patients experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  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.
Sex: U
Vaccine: FLUX
Symptoms: Condition aggravated, Illness
Clinical narrative: sick; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who was sick (illness), after receiving INFLUENZA VACCINE.  The patient's past vaccinations included pneumococcal vaccine in 2005, 2006, 2007 and 2008 followed by adverse reaction pneumonia. In 2006 the patient got it for 2 weeks after the shot; then in 2007 for 6 weeks; then in 2008 for 3 months and had nearly dying experienced. Also had Influenza vaccine every year, the patient and his/her mother got sick every year.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(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 sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "yeah I would not get that pneumonia shot back in 2005 my doctor recommended it I never had pneumonia before in my life and 2006 I got it for 2 weeks after the shot then in 2007 I got it for 6 weeks then in 2008 I got pneumonia again for the third time for 3 months nearly dying. They do not work they actually make you sicker just like the flu shots make you sicker me and my mom used to go down every year to the local Health department get our shots and every year we get sicker and sicker finally we put two and two together you do not want to get a flu shot or a damn COVID (coronavirus disease) shot either."  It was unknown if there were lab data/results available  It was not reported if the patient received any corrective treatment.  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, FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case from social media via consumer/non-health care professional.  This case involves a patient (unknown demographics) 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 (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Only time I ever had the flu was the one time I took a flu shot so no thanks but you go ahead!"  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 the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Cough, Influenza like illness, Rhinorrhoea
Clinical narrative: Flu; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case from social media via consumer/non-health care professional.  This case involves a patient (unknown demographics) 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 (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Only time I ever had the flu was the one time I took a flu shot so no thanks but you go ahead!"  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 the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Gait disturbance, Limb discomfort
Clinical narrative: It knocked the crap out of my legs; Could hardly walk for a week; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves an (unknown demographic) patient who experienced it knocked the crap out of my legs (limb discomfort) and could hardly walk for a week (gait disturbance) while 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 non-serious it knocked the crap out of my legs (limb discomfort) and could hardly walk for a week (gait disturbance) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got a flu shot about 3 weeks ago! It knocked the crap out of my legs! Could hardly walk for a week!"  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.  The event outcome was unknown for all the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick; Initial information received on 05-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (unknown age and gender) who was sick (illness), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s). concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (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) [unknown latency] following the administration of vaccine.  It was reported "No thanks! The last two that I had made me sick when I was perfectly healthy until the shot! I also hear that they are sneaking the covid vaccine in it!"  It was unknown if the patient experienced any additional symptoms/events.  There were no 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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient received ACT-HIB with wrong diluent; mixed with diluent used for MMR with no reported adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health professional via Medical Information (MI) (Reference number- 00787088).  This case involves patient (unknown demographics) who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB], which was mixed with MMR (measles, mumps, and rubella) wrong diluent (Product preparation error).  The patient's medical history, past medical treatment, concomitant medication, vaccination and family history were not provided.  On 24-Sep-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ404AAB and expiry date: 04-Oct-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Wrong solution used in drug reconstitution (latency on same day).  At the time of report no adverse reactions were reported.  It was reported "Caller stated that they mixed ACTHIB with wrong diluent before administration. ACTHIB was mixed with diluent used for MMR. Caller wanting to know what they should do.Caller states that on Friday, 24 Sep 2021, an ACTHIB vaccine was given that had been improperly reconstituted. The ACTHIB was reconstituted with the diluent from an MMR vaccine. Caller does not have patient information at this time, she states that she could obtain it".   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Rash, Somnolence, Swollen tongue, Tongue discolouration, Vaccination complication
Clinical narrative: swollen tongue; sleepiness; swollen tongue, with raised white puffy lines; had Fluzone Quad vaccination in 2009 and had a reaction and had the moderna COVID and had a reaction as well; rash; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Global Media Information (under the reference 00787220).  This case involves a 57 years old female patient who experienced swollen tongue, sleepiness (somnolence), swollen tongue, with raised white puffy lines (tongue discolouration), had fluzone quad vaccination in 2009 and had a reaction and had the moderna covid and had a reaction as well (vaccination complication) and rash after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included LEVOTHYROXINE SODIUM (SYNTHROID).  In 2009, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, total, lot U3261AA and expiration date not provided) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination  On an unknown date the patient developed a non-serious swollen tongue, sleepiness (somnolence), swollen tongue, with raised white puffy lines (tongue discolouration), had fluzone quad vaccination in 2009 and had a reaction and had the moderna covid and had a reaction as well (vaccination complication) and rash (unknown latency) following the administration of vaccines  No laboratory data reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  At time of reporting, the outcome was Unknown for the reported events.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A patient under the age of 18 received flublok with no reported adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (under the reference 00787298).  This case involves an 11 years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] under the age of 18 (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  On 25-Sep-2021, the patient received a dose of suspect FLUBLOK QIV (0.5 ml, total, lot UJ723AA and expiration date: 30-jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to vaccine administered to patient of inappropriate age.  At time of reporting, the outcome was unknown for the reported 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.
Age: 62.0
Sex: M
Vaccine: FLUR4
Symptoms: Expired product administered
Clinical narrative: Patient recieved an expired vaccine with no reported adverse event; Initial information was received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional and non-healthcare professional via Agency (Global Medical Information- 00787339).  This case involves a 62-years old male patient who was vaccinated with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 25-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number QFAA2060 and expiry date 30-Jun-2021 reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  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.
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of ACTHIB was administered to ONE patient with no AE; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a physician via Medical information (MI) number: 00787391.      This case involves a 18-month- old patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).   The Patient's concomitant medications include DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), INFLUENZA VACCINE (INFLUENZA) for prophylactic vaccination respectively.   The patient's medical history, past medical treatments vaccinations and family history were not provided.  On 27-Sep-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE[ACT-HIB] (lot number: UJ391AAA and expiration date 10-Aug-2021) via intramuscular route in unknown administration site for prophylactic vaccination.   It was a case of an actual medication error due to expired product administered (latency same day).    It was reported "Physician called to report that an expired dose of ACTHIB was administered to ONE patient. The caller would like to know whether the dose is valid or whether it should be re-administered".  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.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 59 year old patient was accidentally given FLUZONE HIGH DOSE, even though it's indicated for 65+ with no reported adverse event; Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious inbound case received from a other health professional (Inquiry Number: 00788802 and CompanyNumber: US-SANOFI-00788802) and transmitted to Sanofi on 28-Sep-2021.  This case involved a 59 years old male patient who experienced ''59 year old patient was accidentally given fluzone high dose, even though it's indicated for 65+ with no reported adverse event'' (product administered to patient of inappropriate age) while he received QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.7 ml of suspect QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] produced by Sanofi Pasteur Inc. [lot number- UJ731AA and expiration date 30-Jun-2022], via Intramuscular route at right arm as an administration site for prophylactic vaccination.  It was an actual case of medication error due to inappropriate age at vaccine administration (latency same day).  At time of reporting, the outcome was unknown for the event product administered to patient of inappropriate age.  It was unknown if the patient experienced any additional symptoms/events.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.