chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: ADVERSE REACTION OR SIDE EFFECT EXPERIENCED: NONE; PNEUMOCOCCAL VACCINE ON 29-MAR-2017 AND 02-APR-2018; This spontaneous report was received from a consumer and a physician referring a 64-year-old male patient. The patient's concurrent conditions included type 2 diabetes mellitus and congenital solitary kidney. The patient's family history included cirrhosis and alcoholism (father). The patient's historical conditions included chicken pox. The patient was a retired ex-tobacco user. The patient's historical immunizations included influenza virus vaccine (unspecified) (reported as Influenza) (on 15-OCT-2010 and 13-SEP-2016), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (reported as tdap) (on 15-OCT-2010) and zoster vaccine live (ZOSTAVAX) (on 05-FEB-2015). The patient's historical drugs included valacyclovir hydrochloride, metoprolol tartrate, nitroglycerin, ticagrelor (BRILINTA), aspirin, atorvastatin and lisinopril. The patient's concomitant medications included aspirin, lisinopril (manufacturer unknown), atorvastatin, nebivolol hydrochloride (BYSTOLIC), and metformin.  On 17-DEC-2015, the patient experienced herpes zoster; and on 15-JAN-2016, he experienced acute myocardial infarction, acute coronary syndrome, coronary artery disease tear (all captured in reporting system # 2003USA004439).  On 29-MAR-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis; and on 02-APR-2018, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration). It was reported that the patient did not experienced any adverse reactions or side effects as a result of both immunizations.; Sender's Comments:  US-009507513-2003USA004439:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed to take second dose of Vivotif; Spontaneous case was received from pharmacist on 21OCT2020.  A pharmacist reported that a 19-year-old male consumer "missed to take second dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunization. This male consumer took the first dose of Vivotif on 18OCT2020 and missed to take his second dose of Vivotif, which was due on 20OCT2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer missed to take his second dose of Vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer missed to take his second dose of vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is assessed as not applicable to vivotif due to the nature of the event.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Diarrhoea, Dysphagia, Dyspnoea, Feeling abnormal
Clinical narrative: sneezing; difficulty breathing; throat started to close down which was really bothering; fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit); vomiting; stomach began to feel nauseous; feeling awful/ felt worse; hardly swallow; diarrhea; retching; Initial information was received on 12-Oct-2020 regarding an unsolicited valid serious case from a nurse via sales representative.  This case involves an 82-years-old female patient who experienced sneezing, difficulty breathing (dyspnoea), throat started to close down which was really bothering (oropharyngeal discomfort with symptom of dysphagia), fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit) (pyrexia), vomiting (with symptoms of abdominal discomfort, diarrhoea, feeling abnormal and retching), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, family history and concomitant medication/therapy were not provided.   On 08-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [batch number, expiry date and other dosing details not reported] for prophylactic vaccination.  On an unknown date, in Oct-2020, the patient developed a serious vomiting, sneezing, difficulty breathing (dyspnoea) few days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   On the same day, at afternoon, the patient had close down of throat (oropharyngeal discomfort) and then stomach began to feel nauseous (abdominal discomfort).   It was reported that, patient had appointment at heart clinic at 01:30 pm and by the time she felt awful (feeling abnormal), throat was very bothering and hardly swallow (dysphagia) then felt worse and within an hours had diarrhea (diarrhoea), vomiting, retching and fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit) (pyrexia).  These events were assessed as life-threatening. The patient was hospitalized for these events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient was recovered from all the reported events.  Information on the batch number was requested.; Sender's Comments: This case involves an 82-years-old female patient who had a life threatening condition of sneezing, dyspnoea, oropharyngeal discomfort with symptom of dysphagia), pyrexia and vomiting with symptoms of abdominal discomfort, diarrhoea, feeling abnormal and retching few days after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible with role of vaccine. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, concomitant medication/therapy, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Oropharyngeal discomfort, Pyrexia, Retching, Sneezing
Clinical narrative: sneezing; difficulty breathing; throat started to close down which was really bothering; fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit); vomiting; stomach began to feel nauseous; feeling awful/ felt worse; hardly swallow; diarrhea; retching; Initial information was received on 12-Oct-2020 regarding an unsolicited valid serious case from a nurse via sales representative.  This case involves an 82-years-old female patient who experienced sneezing, difficulty breathing (dyspnoea), throat started to close down which was really bothering (oropharyngeal discomfort with symptom of dysphagia), fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit) (pyrexia), vomiting (with symptoms of abdominal discomfort, diarrhoea, feeling abnormal and retching), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, family history and concomitant medication/therapy were not provided.   On 08-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [batch number, expiry date and other dosing details not reported] for prophylactic vaccination.  On an unknown date, in Oct-2020, the patient developed a serious vomiting, sneezing, difficulty breathing (dyspnoea) few days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   On the same day, at afternoon, the patient had close down of throat (oropharyngeal discomfort) and then stomach began to feel nauseous (abdominal discomfort).   It was reported that, patient had appointment at heart clinic at 01:30 pm and by the time she felt awful (feeling abnormal), throat was very bothering and hardly swallow (dysphagia) then felt worse and within an hours had diarrhea (diarrhoea), vomiting, retching and fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit) (pyrexia).  These events were assessed as life-threatening. The patient was hospitalized for these events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient was recovered from all the reported events.  Information on the batch number was requested.; Sender's Comments: This case involves an 82-years-old female patient who had a life threatening condition of sneezing, dyspnoea, oropharyngeal discomfort with symptom of dysphagia), pyrexia and vomiting with symptoms of abdominal discomfort, diarrhoea, feeling abnormal and retching few days after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible with role of vaccine. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, concomitant medication/therapy, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Vomiting
Clinical narrative: sneezing; difficulty breathing; throat started to close down which was really bothering; fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit); vomiting; stomach began to feel nauseous; feeling awful/ felt worse; hardly swallow; diarrhea; retching; Initial information was received on 12-Oct-2020 regarding an unsolicited valid serious case from a nurse via sales representative.  This case involves an 82-years-old female patient who experienced sneezing, difficulty breathing (dyspnoea), throat started to close down which was really bothering (oropharyngeal discomfort with symptom of dysphagia), fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit) (pyrexia), vomiting (with symptoms of abdominal discomfort, diarrhoea, feeling abnormal and retching), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, family history and concomitant medication/therapy were not provided.   On 08-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [batch number, expiry date and other dosing details not reported] for prophylactic vaccination.  On an unknown date, in Oct-2020, the patient developed a serious vomiting, sneezing, difficulty breathing (dyspnoea) few days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   On the same day, at afternoon, the patient had close down of throat (oropharyngeal discomfort) and then stomach began to feel nauseous (abdominal discomfort).   It was reported that, patient had appointment at heart clinic at 01:30 pm and by the time she felt awful (feeling abnormal), throat was very bothering and hardly swallow (dysphagia) then felt worse and within an hours had diarrhea (diarrhoea), vomiting, retching and fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit) (pyrexia).  These events were assessed as life-threatening. The patient was hospitalized for these events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient was recovered from all the reported events.  Information on the batch number was requested.; Sender's Comments: This case involves an 82-years-old female patient who had a life threatening condition of sneezing, dyspnoea, oropharyngeal discomfort with symptom of dysphagia), pyrexia and vomiting with symptoms of abdominal discomfort, diarrhoea, feeling abnormal and retching few days after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible with role of vaccine. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, concomitant medication/therapy, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flu; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional (patient).   This case involves patient [age and gender unspecified] who got the flu, while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient  got the flu shot for 15 years and got the flu every year. Patient haven't got flu for 30 years.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: patient got flu; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional (patient).   This case involves patient [age and gender unspecified] who got the flu, while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient was going to die. The shot did not give the flu, it just was not effective that year.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Pyrexia, Viral test
Clinical narrative: flu; developed a fever; Initial information was received on 15-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient's son) via social media.  This case involves a patient of unknown age who developed a fever (pyrexia) and Flu (Influenza), when patient recieved Influenza Vaccine.  Medical history, medical treatment, past vaccination and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown), following vaccination reporter's mother went to her doctor fine no signs of anything wrong according to her doctor a check that he made before administering the flu shot shortly afterwards at home she developed a fever (pyrexia) called the doctor he asked to come right in he examined her took swabs then after reading told her she had the flu (Influenza). Reporter stated (information not hear say because I took her to the doctor both times and I still have the documents which state his findings so before you post a bogus claim that the flu shot does not give you the flu get real facts or do more research)  Other relevant laboratory test were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: the influenza vaccine had made patient Ill many times; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 17-Nov-2020.  This case involved patient an unknown age who reported that the influenza vaccine had made patient ill many times (illness).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received INFLUENZA VACCINE (produced by unknown manufacturer lot number unknown via an unknown route in an unknown administration site prophylactic vaccination)   On an unknown date (latency unknown), the patient had ill many times (illness).   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for illness.  There will be no information regarding the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves a 56-years-old patient who experienced flu (influenza), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick with a flu shot; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (patient) via Social media on 20-Nov-2020.  This case involved a patient of an unknown patient who got sick with a flu shot (Illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient got sick with a flu shot (Illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient get  sick from flu shot; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional (patient).   This case involves patient [age and gender unspecified] who got sick (illness) while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick from flu shot (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional (patient).   This case involves patient [age and gender unspecified] who got the flu (influenza), while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, every time patient taken the flu shot. Patient got the flu.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Headache
Clinical narrative: flu like symptoms; chills; headache; lost taste; lost smell; corona test was positive; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and transmitted to Sanofi on 19-Nov-2020.  This case involves patient of unknown demographics who reported of being affected with COVID-19, characterized by flu like symptoms (influenza like illness), chills, headache, lost taste (ageusia) and lost smell (anosmia) after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concomitant medications were not provided.   On an unknown date in Septembeer-2020, the patient took INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in November-2020, 2 months after the initiation of therapy with INFLUENZA VACCINE (reported 2 weeks ago), the patient started suffering from flu-like symptoms (influenza like illness). The patient was sure that it was not flu and hence had done corona test on an unknown date in 2020 (latency unknown), the result of which was positive (COVID-19). On an unknown date in 2020, (latency unknown) the patient started suffering from chills, headache, had lost taste (ageusia) and lost smell (anosmia).   It was not reported if the patient received a corrective treatment.  Event outcome was reported as resolving for the event as the patient had reported to be better at the time of reporting.   There will be no information regarding the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness, SARS-CoV-2 test positive
Clinical narrative: flu like symptoms; chills; headache; lost taste; lost smell; corona test was positive; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and transmitted to Sanofi on 19-Nov-2020.  This case involves patient of unknown demographics who reported of being affected with COVID-19, characterized by flu like symptoms (influenza like illness), chills, headache, lost taste (ageusia) and lost smell (anosmia) after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concomitant medications were not provided.   On an unknown date in Septembeer-2020, the patient took INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in November-2020, 2 months after the initiation of therapy with INFLUENZA VACCINE (reported 2 weeks ago), the patient started suffering from flu-like symptoms (influenza like illness). The patient was sure that it was not flu and hence had done corona test on an unknown date in 2020 (latency unknown), the result of which was positive (COVID-19). On an unknown date in 2020, (latency unknown) the patient started suffering from chills, headache, had lost taste (ageusia) and lost smell (anosmia).   It was not reported if the patient received a corrective treatment.  Event outcome was reported as resolving for the event as the patient had reported to be better at the time of reporting.   There will be no information regarding the batch number for the case.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: patient received expired Pentacel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via phone at call center as a medication inquiry on 23-Nov-2020.  This case involved a four-month-old female patient who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant vaccines included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX).  There was an actual medication error due to expired vaccine used.  On 21-Nov-2020, the patient received an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Expired product administered) 0.5 mL (lot number: UJ053AA, expiry date: 27-Dec-2020) via intramuscular route in an unknown administration site for prophylactic vaccination.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional (patient).   This case involves patient [age and gender unspecified] who got the flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Facial nerve disorder
Clinical narrative: nerve facial issues; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient's wife) via social media.  This case involves a male patient of unknown age who was suffering from nerve facial issues (facial nerve disorder), after patient was vaccinated with INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination, family history and concomitant medication was not reported.  On an unknown date in 2019, the patient received INFLUENZA VACCINE [lot number and expiration date unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in 2019, (latency unknown) after starting the INFLUENZA VACCINE therapy, the patient was suffering from nerve facial issues (facial nerve disorder). Naturopath advised could be from the additives in the INFLUENZA VACCINE as well as metals. Healthy diet, supplements and good hygiene was the corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: patient is taking dupixent 300mg qow for asthma; patient received a flu shot and now has a rash on their arm; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious case received from a physician via Sales Representative.  This case involves a male patient of unknown age who received a flu shot and now has a rash on their arm and patient is taking dupixent 300mg every other week for asthma, while he was treated with dupilumab (Dupixent) via unknown device and Flu vaccine.   The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 11-Aug-2020, the patient started taking dupilumab 300mg every other week (strength, route, formulation, lot number and expiry date unknown) for asthma (product use issue) (Latency: same day). Information on batch number was not requested in context of COVID-19. On an unknown date, the patient took flu vaccine (dose, strength, form, route, frequency and batch number unknown for an unknown indication)  On an unknown date of 2020 (Latency: unknown), the patient received a flu shot and now has a rash on their arm (rash). Patient does not inject dupixent in the arm. Office wants to know if the combination of Dupixent and the flu shot caused the rash.  Action taken: Unknown for rash and not applicable for product use issue for both suspects  Corrective: Unknown for rash  Outcome: Recovered on an unknown date of 2020 for rash and not applicable for product use issue  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Impaired work ability, Malaise
Clinical narrative: ended up sicker than ever been in patient's life; Initial information regarding an unsolicited valid serious case received from a consumer (patient) via social media and transmitted to Sanofi on 12-Dec-2020.  This case involves patient with unknown demographics who reported that the one time patient took influenza vaccine ended up sicker than ever been in patient's life, hospitalized and missed 2 weeks of work (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient took INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination and ended up sicker than ever been in patient's life (illness) due to which the patient was hospitalized and missed work for 2 weeks.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for illness.  There will be no information regarding the batch number for the case.; Sender's Comments: This case involves patient with an unknown age who had illness after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Further information regarding previous vaccination, tolerance and laboratory tests ruling out alternate etiologies are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: took a flu shot spent a week in the hospital and had an allergic reaction to it; Initial information received on 12-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer (Patient).  This case involved an adult patient who had allergic reaction (took a flu shot and spent a week in the hospital due to an allergic reaction)(Hypersensitivity), after patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient took a flu shot spent a week in the hospital and had an allergic reaction to it (Hypersensitivity), unknown latency following the administration of INFLUENZA VACCINE.   The patient was hospitalized (caused or prolonged) for this event for one week.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns patient with unknown demographics who took a flu shot and had an allergic reaction to it (Hypersensitivity) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. However, concomitant medications, patient's medical condition at time of vaccination and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: gullian barre syndrome; Initial information regarding an unsolicited valid serious case was received from a consumer/non-healthcare professional (patient) via social media on 11-Dec-2020.  This case involved a patient of unknown demographics who got Guillain Barre syndrome, after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient got one flu shot and got Guillain Barre syndrome. The event was assessed as medically significant as per the important medical event (IME) list.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves a patient of an unknown age and gender who presented with Guillain Barre syndrome after receiving INFLUENZA VACCINE by an unknown manufacturer. Time to onset is unknown. Although, medical history, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: the patient received two doses of Fluzone High Dose Quadrivalent vaccination within 1 hour on the same day; Initial information regarding this unsolicited valid serious case received from other health professional on 11-Dec-2020.  This case involves an 80 year old female patient with dementia who received two doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within 1 hour on the same day (extra dose administered).  Relevant past medical treatment, vaccination details, concomitant medications and family history were not provided. No other vaccines were administered. Medical history includes ongoing dementia.   On 11-Dec-2020, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ512AA, expiry date- 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic and again with another dose of 0.7 ml within 1 hour on the same day (extra dose administered).   It was reported that after receiving the vaccination the patient was then supposed to go to the lab, however she started to go home because she suffered from dementia, so they called her back and redirected her to the lab. The patient then went back to the clinic again requesting a flu shot even though she just received one. The original nurse that provided the injection, went to lunch and another nurse gave the patient another Fluzone High Dose Quadrivalent. The caller would like to know how to proceed as far as caring for the patient.  It was a case of actual medication error due to extra dose administered.  Relevant laboratory test was not reported.
Sex: U
Vaccine: FLUR4
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: 4 of the patients ended up with a rash near the injection site and down the arm; The other 3 patients it almost felt like an infection. The injection site was swollen for almost 2 weeks; The other 3 patients it almost felt like an infection. The injection site was warm for almost 2 weeks; Initial information was received on 14-Dec-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves 10 patients of unknown age and among 4 of the patients ended up with a rash near the injection site and down the arm (vaccination site rash) and the other 3 patients it almost felt like an infection. the injection site was swollen and warm for almost 2 weeks (vaccination site swelling and vaccination site warmth), while patients was treated with influenza quadrivalent recombinant vaccine [Flublok QIV].  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza quadrivalent recombinant vaccine [lot number: QFAA2016 and expiration date: 30-Jun-2021] at a dose of 0.5 ml once via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, 4 of the patients ended up with a rash near the injection site and down the arm (vaccination site rash) and the other 3 patients it almost felt like an infection. the injection site was swollen and warm for almost 2 weeks (vaccination site swelling and vaccination site warmth).  The patient was treated with hydrocortisone for vaccination site rash and antibiotics for vaccination site swelling and vaccination site warmth.  At the time of reporting, outcome of the events was resolved on an unknown date.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Laboratory test normal, Pain, Pyrexia
Clinical narrative: patient got flu shot on 09/01 and on 09/02 1:00 in morning woke up with body aches. At about 7 to 8 am patient had to call 911. He describe symptom as having extreme back pain which felt like snap back and hit by a car. He also had a fever of 102 degree.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Started with onset of fatigue and disorientation shortly after receiving the vaccine. Several hours after the disorientation got worse, a headache came on and my whole body aches fatigue is bad. I feel like the flu just hit me.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: Sore arm at point of injection Some ache Slight temperature (91.1)
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lacrimation increased, Swelling face, Throat irritation
Clinical narrative: Allergic reaction with facial swelling, eye tearing, "itchy" throat
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dry throat, Rash
Clinical narrative: Systemic rash, dry cough (causing cough); 650mg Tylenol every 6; 50mg Benadryl to start then 25 mg every 6, Pepcid 20mg every 12 hours; rash is slowly resolving; throat still very dry with dry cough
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Rash
Clinical narrative: Systemic rash, dry cough (causing cough); 650mg Tylenol every 6; 50mg Benadryl to start then 25 mg every 6, Pepcid 20mg every 12 hours; rash is slowly resolving; throat still very dry with dry cough
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial flutter, Electrocardiogram abnormal, Headache, Heart rate increased
Clinical narrative: Later in the day, after receiving his second dose of Shingrix, he noticed a fast heart rate on his Apple Watch. Normal HR is 40s to 50s and HR was greater than 90, sometimes in the 110s. No lightheadedness or other CV symptoms. Seen in clinic the next day, on ECG he had atrial flutter with 2:1 AV conduction. His only other new symptoms that he attributed to the Shingrix was headache. He is going to follow up remotely with his Cardiologist (electrophysiology specialist) within 1-2 days.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: After I got the vaccine, the next day in the morning, while driving my kids to school, I felt my scalp was itchy. Initially I thought maybe it?s because I?m sweating so that?s why it felt itchy. But the itch persisted. I didn?t notice any rash then and my head is covered with hair. Around noon, I went to the gym to work out and while headed to the locker room I felt my scalp itching was getting worse. Once I started taking a shower though, my entire body broke out in hives with intense itching everywhere. I have never experienced anything like this before. I headed home and had a Benadryl. It helped somewhat but itching was still intense. I also had fexofenidine tablet . The next day I still had the hives and the itchiness so I had the fexofenqdine tablet again. This continued for a few days and then stopped
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea started about  8 hours after getting vaccine and progressively got worse over 12 hours
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: Awoke shivering at 11:30 pm with chills; injection site was very sore. Took ibuprofen and fell asleep. Awoke 2 hours later feeling better with no chills. Writing this at 7:30 am, 8 hours after awaking with chills, and still feel better. Injection site not as tender. Pulse oximeter just now  (after shower) reports 95% O2 and a pulse rate of 111.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea, Pyrexia
Clinical narrative: Day 0 of injection that evening , experienced fevers, chills, rigors, malaise. Day 1 morning experienced nausea
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Gait inability
Clinical narrative: 60 minutes after receiving the vaccine the patient became very dizzy and was unable to walk. After a couple of hours dizziness lessened and patient was able to ambulate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Pruritus, Tachycardia, Urticaria
Clinical narrative: Patient presented with feeling of "headrush" dizziness, tachycardia to 130's, itching  to neck,  visible hives to face and neck.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Injection site pain, Pruritus, Rash
Clinical narrative: Patient presented with feeling of "headrush" dizziness, tachycardia to 130's, itching  to neck,  visible hives to face and neck.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor, Urticaria
Clinical narrative: Patient presented with feeling of "headrush" dizziness, tachycardia to 130's, itching  to neck,  visible hives to face and neck.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Injection site pain, Myalgia
Clinical narrative: Patient presented with feeling of "headrush" dizziness, tachycardia to 130's, itching  to neck,  visible hives to face and neck.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Pruritus, Rash, Urticaria
Clinical narrative: Patient presented with feeling of "headrush" dizziness, tachycardia to 130's, itching  to neck,  visible hives to face and neck.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: Hives within 3 hours lasted 12 hours. Left Arm edema and erythema 24 hours
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever 100.3, chills, headache
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: L shoulder has continued to hurt from the shot.  Had shooting pain and soreness down to her wrist initially.  But went away after about a week.  Now with lifting the shoulder it is sore.  And when tries to sleep at night it hurts on  that side.   Is able to do yoga - but with certain stretches it hurts, reported 1 month after flu vaccine given. Pain with full ROM, but able to do it.  (11/24/2020).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Chills approx 6 hours after receiving shot Injection site tenderness (no redness or swelling noted) Muscle aches and joint pain at 8 hours At 12 hours, fatigue, nausea (20 minutes), headache, congestion, low grade temp 99.5, malaise  Hour 17 fever to 100.5 took 800 mg Advil and 1000 mg Tylenol.  Hour 24 all symptoms completely resolved only very mild injection site tenderness. Felt at baseline.  Afebrile.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Respiratory tract congestion
Clinical narrative: Chills approx 6 hours after receiving shot Injection site tenderness (no redness or swelling noted) Muscle aches and joint pain at 8 hours At 12 hours, fatigue, nausea (20 minutes), headache, congestion, low grade temp 99.5, malaise  Hour 17 fever to 100.5 took 800 mg Advil and 1000 mg Tylenol.  Hour 24 all symptoms completely resolved only very mild injection site tenderness. Felt at baseline.  Afebrile.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling hot, Pruritus
Clinical narrative: Extreme fatigue, felt very warm all over body for 14 - 16 hours, exceptional pruritus on head and back, all joints are exceptionally achey