chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray abnormal
Clinical narrative: yeast infection with her shoulder; left shoulder has arthritis; bursitis; Initial information regarding an unsolicited valid non-serious case was received from a Patient via agency (Reference number- 00354717) and transmitted to Sanofi on 11-Nov-2020.  This case involves a 74 year old female patient who experienced yeast infection with her shoulder (Fungal infection), left shoulder has arthritis (Arthritis) and bursitis while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  Medical history, concurrent conditions, vaccination(s) and family history were not provided. Concomitant medication was unknown.  In October 2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE in her left arm and that the was injection was given, "at the highest point on her arm, close to the bone in her shoulder, (lot number: UJ236AA) via unknown route at an unknown administration site as prophylactic vaccination.    On an unknown date, she could not tell exactly where they gave the shot, but it was not like her previous shots. She recalled the staff who administered the injection was "on her 2nd day". The next day she could not move or lift her left arm, she stated she continues to have issues and it was still sore. She also experienced a yeast infection and said, " I thought my insides were coming out." Consumer reported she never had a yeast infection or issues with her shoulder before receiving the FLUZONE HIGH DOSE vaccine. Also reported that her doctor did not tell her it was a different shot than the ones she received in the past, or what the possible side effects are. X Rays were taken and her doctor said her left shoulder has arthritis and bursitis and one more condition the consumer could not recall. Consumer stated she will never get any kind of shot from this experience. She requested an anatomical shoulder image to be included in the letter. This way she can mark where the injection was given because she feels it was given too high.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for all events.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: She said that a "little bit" of the vaccine leaked out of the syringe where the needle connects to it because "it was loose"; she didn't get her full dose; Initial information regarding an unsolicited valid non-serious case was received from a physician on 11-Nov-2020.  This case involves a 73 years old female patient who said that a "little bit" of the vaccine leaked out of the syringe where the needle connects to it because "it was loose" (Device connection issue) and she didn't get her full dose (Incorrect dose administered), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was reported.  On 30-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ536AA and expiration date: unknown) 0.7 ml once via unknown route in unknown administration site for prophylactic vaccination.  On 30-Oct-2020, on the same day the patient said that a "little bit" of the vaccine leaked out of the syringe where the needle connects to it because "it was loose" and she didn't get her full dose". It was actual medication error case due to incomplete dose administered.    Action taken and event outcome were not applicable for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  No further relevant information was reported.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient was given PENTACEL without diluent with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional on 11-Nov-2020.  This case involves a 2 months 3 days old male patient was given pentacel without diluent with no adverse event (Product preparation issue), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication included Rotavirus, Prevnar, Hepatitis B.  On 09-Nov-2020, the patient received only the liquid part of a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ536AA and expiration date: 24-Apr-2021) (Liquid- lot number: UJ395AA expiration date: 24-Apr-2021, and Powder- Lot number:  UJ159AA expiration date: 24-Apr-2021) 0.5 ml once via intramuscular route in right thigh for prophylactic vaccination.  On 09-Nov-2020, on the same day it was reported that the patient was given PENTACEL without diluent.  It was actual medication error case due to inappropriate dilution of medication.  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.  No further relevant information was reported.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Off label use
Clinical narrative: gotten 2 Fluzone HD vaccination, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via agency (Reference number- 00355247) and transmitted to Sanofi on 11-Nov-2020.  This case involves an unknown age male patient who gotten 2 fluzone high dose (HD) vaccination, with no adverse event (Off label use), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, concurrent conditions, vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) via unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, patient gotten 2 fluzone high dose (HD) vaccination, with no adverse event (Off label use).  No laboratory data were reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as not applicable for off label use.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: reports 4 year old was given Fluzone HD with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse on 12-Nov-2020.  This case involves a 4 years old female patient was given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event (Product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 11-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ479AA and expiration date: 30-Jun-2021) 0.7 ml once via intramuscular route in right deltoid for prophylactic vaccination.  It was potential medication error case due to product administered to patient of inappropriate age.    Action taken and event outcome were not applicable for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  No further relevant information was reported.
Sex: F
Vaccine: FLUR4
Symptoms: Adverse event, Magnetic resonance imaging normal, Pain in extremity
Clinical narrative: patient then saw a physician for arm pain; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 61 years old female patient who experienced patient then saw a physician for arm pain (pain in extremity), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE once (lot UJ463AA and expiration date 19-Mar-2021) via unknown route in unknown administration site,for prophylactic vaccination.  On an unknown date (latency unknown), it was reported that, the patient received a flu shot with Flublok in her left arm.  There maybe was a little knot there after the vaccine.  The nurse caller stated she is assuming it continued.  The patient then saw a physician for arm pain (pain in extremity).  The physician told her it was most likely an adverse event due to the flu shot.  The patient then had an MRI for the arm pain.  The Magnetic resonance imaging (MRI) came back normal.  The arm pain continues.  The nurse stated that the patient says she is going to pursue this.       No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment..  Outcome of the event was Not Resolved at the time of reporting.
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pharmacist had given Flublok and the patient complained because she wanted the HD Fluzone with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a pharmacist and transmitted to Sanofi on 12-Nov-2020.  This case involves a 77 years old female patient  to whom pharmacist had given QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) and the patient complained because she wanted the QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) (product dispensing error) at an unknown dose, (batch number and expiry date unknown) at an unknown administration site via unknown route, for prophylactic vaccination.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.   It was an actual medication error case since the patient wanted QUADRIVALENT INFLUENZA VACCINE, however, the patient was provided with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE by the pharmacist (product dispensing error).  At the time of this report, no adverse event symptoms reported.  The pharmacist also reported that the patient stated that in the hospital they gave the QUADRIVALENT RECOMBINANT INFLUENZA VACCINE and not the QUADRIVALENT INFLUENZA VACCINE and the reasons were 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.  There will be no information regarding the batch number for the case.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received an extra dose of Fluzone Quadravalent, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health care professional (Reference number- 00356778) and transmitted to Sanofi on 12-Nov-2020.  This case involves a 4-year-old male patient who received an extra dose of influenza quadrival a-b vaccine [Fluzone Qiv], with no adverse event (extra dose administered).  Medical history, concurrent conditions, vaccination(s) and family history were not provided. Concomitant medication was unknown.  On 12-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE 0.5 mL (lot number: UT7065LA) via an unknown route as prophylactic vaccination.  On an unknown date, received an extra dose of Fluzone Quadravalent, with no adverse event.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as not applicable for extra dose administered.  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: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives; Initial information regarding an unsolicited valid non-serious case received via an other health professional on 13-Nov-2020.  This case involves an unknown age female patient who experienced hives (urticaria), while treated with influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.   On an unknown date, the patient received a dose  dose of suspect influenza quadrival a-b high dose hv vaccine (Lot number and expiry date unknown) at an unknown dose, frequency via unknown route at an unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, patient experienced hives (urticaria).   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: supposed to give Fluarix accidentally grabbed and administered Fluzone High Dose Quadrivalent, with no AE; Initial information regarding an unsolicited valid non-serious case received via an other health professional on 13-Nov-2020.  This case involves a 44 year old female patient who was supposed to take fluarix, however grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] accidentally (wrong product administered) (batch number: UJ552AA and expiration date: 30-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) family history and concomitant medications were not provided.  This was an actual medication error case due to the event wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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 and Regulatory Authority 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: 6.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: they experienced a temperature excursion for opened Ipol, reached a low temperature of 1.7C and out of range for 1 hour, with no AE; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 6 years old female patient for whom it was reported they experienced a temperature excursion for opened ipol, reached a low temperature of 1.7c and out of range for 1 hour (product storage error), while she started therapy with vaccine IPV (Vero) [Ipol], suspension for injection, 0.5 ml once via unknown route (Batch number: R1D972M and Expiry date: 17-Jul-2021) for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), concurrent conditions and family history were not provided. Concomitant medication was not reported.   Final diagnosis was they experienced a temperature excursion for opened ipol, reached a low temperature of 1.7c and out of range for 1 hour.  No lab data 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding the batch number.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: received  one 2 months ago in September and got one on 10NOV2020; soreness at the injection site; Initial information regarding an unsolicited valid non-serious case received via a pharmacist on 13-Nov-2020.  This case involves an unknown age male patient who experienced soreness at the injection site (injection site pain) and received one 2 months ago in september and got one on 10nov2020 (extra dose administered), while treated with influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.   On an unknown date in September 2020, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (lot number: UJ540AA, expiry date: 30-Jun-2021) at an unknown dose, frequency via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2020, (unknown latency) after starting the suspect vaccine therapy the patient had soreness at the injection site (injection site pain).  On 10-Nov-2020, approximately two months after starting the suspect vaccine therapy patient got another dose (extra dose administered).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event injection site pain was unknown.  Disclaimer: 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: 52.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pharmacist was supposed to give Fluarix, but accidentally grabbed and administered Fluzone High Dose Quadrivalent to a patient, No AE; a 52 years old patient was accidentally administered Fluzone High Dose Quadrivalent, No AE; a 52 years old patient was accidentally administered Fluzone High Dose Quadrivalent, No AE; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from the other health care professional via agency (Reference number- 00358445.  This case involves a 52 years old male patient who was supposed to give INFLUENZA VACCINE INACT SPLIT 3V [FLUARIX], but the pharmacist accidentally grabbed and administered a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Prefilled Syringe lot UJ552AA, expiry date: 30-JUN-2021 via intramuscular route in the right arm on 05-Nov-2020 for prophylactic vaccination (Wrong product administered, product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No other vaccines given.  This was a case of an actual medication error case due to the event wrong vaccine administered and inappropriate age at vaccine administration  (latency: same day).  It was also a case of overdose. (latency: same day).  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.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to a patient, with no AE; a 54 years old patient was accidentally administered Fluzone High Dose Quadrivalent, No AE; a 54 years old patient was accidentally administered Fluzone High Dose Quadrivalent, No AE; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from the other health care professional via Medical Information (Reference number- 00358460).  This case involves a 54 years old female patient who was supposed to give INFLUENZA VACCINE INACT SPLIT 3V [FLUARIX], but the pharmacist accidentally grabbed and administered a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Prefilled Syringe lot UJ567AB, expiry date: 30-JUN-2021 via intramuscular route in the left arm on 09-Nov-2020 for prophylactic vaccination (Wrong product administered, product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No other vaccines given.  This was a case of an actual medication error case due to the event wrong vaccine administered and inappropriate age at vaccine administration  (latency: same day).  It was also a case of overdose (latency: same day).  No adverse event were noted and no treatments were administered to the patient.  Product used: Used.  First time product used: Yes.  Still using product : No. 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13 year patient had been given the Flublok Quad by mistake,no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00358544) and transmitted  on 16-Nov-2020.  This case involves a 13 year old patient (gender not specified) had been given the 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] by mistake via unknown route in unknown administration site for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age)  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  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 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: 45.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to a patient, with no AE; a 45 years old patient received Fluzone High Dose Quadrivalent accidentally, with no AE; a 45 years old patient received Fluzone High Dose Quadrivalent accidentally, with no AE; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from the other health care professional via Medical Information (MI) (Reference number- 00358658).  This case involves a 45 years old male patient who was supposed to give INFLUENZA VACCINE INACT SPLIT 3V [FLUARIX], but the pharmacist accidentally grabbed and administered a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Prefilled Syringe lot UJ567AB, expiry date: 30-JUN-2021 via intramuscular route in the left arm on 06-Nov-2020 for prophylactic vaccination (Wrong product administered, product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No other vaccines given.  This was a case of an actual medication error case due to the event wrong vaccine administered and inappropriate age at vaccine administration  (latency: same day).  It was also a case of overdose. (latency: same day).  No adverse event were noted and no treatments were administered to the patient.  Product used : Used.  Still using product : No.  Was Device Used : Yes.  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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Loss of consciousness
Clinical narrative: passing out (losing consciousness); Seriousness criteria: medically significant.  Initial information was received on 14-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient).  This case involves a female patient (in her 20's) who passed out (losing consciousness) (loss of consciousness), after she received INFLUENZA VACCINE  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient just participated in a track meet, and immediately afterwards received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination, over 30 years ago.  On an unknown date, the patient passed out (losing consciousness) (loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. She was taken to the hospital. She did not receive any flu shot since that time.   This event was assessed as medically significant.  No laboratory data was provided.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient recovered from the event.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a female patient who had loss of consciousness after vaccination with IFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pruritus, Sleep disorder
Clinical narrative: hives on the arm from her shoulder to her elbow on the inside and outside of the arm with itching and one hive on the left arm; she could not sleep on it; right arm was painful and swollen at the injection site hot to touch and she couldn't sleep on it; right arm was painful; swollen at the injection site; injection site was hot to touch; Initial information regarding an unsolicited valid non-serious case was received from a consumer via agency (Reference number- 00360572) and transmitted to Sanofi on 16-Nov-2020  This case involves a six-year-old female patient who experienced hives on the arm from her shoulder to her elbow on the inside and outside of the arm with itching and one hive on the left arm (urticaria) and right arm was painful and swollen at the injection site hot to touch and she could not sleep on it (vaccination site inflammation, vaccination site pain, vaccination site swelling, vaccination site warmth and insomnia), while she received INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medications and family history were not provided.  It was reported that she was not allergic to eggs but they are going to ask if she can see an allergist since she had this experience last year with the influenza vaccine but feels this year was worse and reporter does not want patient to go through that again.  On 11-Nov-2020, the patient received a 0.5 mL dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in the right arm for prophylactic vaccination.  On 13-Nov-2020, the patient's right arm was painful and swollen at the injection site hot to touch and she could not sleep on it (vaccination site inflammation, vaccination site pain, vaccination site swelling, vaccination site warmth and insomnia) 2 days following the administration of INFLUENZA VACCINE.  On 15-Nov-2020, the patient developed hives on the arm from her shoulder to her elbow on the inside and outside of the arm with itching and one hive on the left arm (urticaria) 5 days following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  The patient was treated with topical cortisone cream and diphenhydramine hydrochloride (benadryl childrens).  At the time of reporting, outcome was unknown for the events.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: hives on the arm from her shoulder to her elbow on the inside and outside of the arm with itching and one hive on the left arm; she could not sleep on it; right arm was painful and swollen at the injection site hot to touch and she couldn't sleep on it; right arm was painful; swollen at the injection site; injection site was hot to touch; Initial information regarding an unsolicited valid non-serious case was received from a consumer via agency (Reference number- 00360572) and transmitted to Sanofi on 16-Nov-2020  This case involves a six-year-old female patient who experienced hives on the arm from her shoulder to her elbow on the inside and outside of the arm with itching and one hive on the left arm (urticaria) and right arm was painful and swollen at the injection site hot to touch and she could not sleep on it (vaccination site inflammation, vaccination site pain, vaccination site swelling, vaccination site warmth and insomnia), while she received INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medications and family history were not provided.  It was reported that she was not allergic to eggs but they are going to ask if she can see an allergist since she had this experience last year with the influenza vaccine but feels this year was worse and reporter does not want patient to go through that again.  On 11-Nov-2020, the patient received a 0.5 mL dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in the right arm for prophylactic vaccination.  On 13-Nov-2020, the patient's right arm was painful and swollen at the injection site hot to touch and she could not sleep on it (vaccination site inflammation, vaccination site pain, vaccination site swelling, vaccination site warmth and insomnia) 2 days following the administration of INFLUENZA VACCINE.  On 15-Nov-2020, the patient developed hives on the arm from her shoulder to her elbow on the inside and outside of the arm with itching and one hive on the left arm (urticaria) 5 days following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  The patient was treated with topical cortisone cream and diphenhydramine hydrochloride (benadryl childrens).  At the time of reporting, outcome was unknown for the events.  There will be no information on the batch number for this case.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Dyspnoea, Fatigue, Intensive care, Mechanical ventilation
Clinical narrative: multiple pneumonias caused by an viral interstitial infection; fatigue; Shortness of breath; back pain; pain in the left arm and hand; Initial information was received on 16-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health professional.   This case involves a 77-years-old male patient who experienced multiple pneumonias caused by a viral interstitial infection (pneumonia viral), fatigue, shortness of breath (dyspnoea), back pain and pain in the left arm and hand (pain in extremity), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 04-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE injection (lot number: UJ444AA, expiry date- 30-Jun-2021, strength: standard) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 04-Sep-2020, the patient developed serious back pain, pain in the left arm and hand (pain in extremity), fatigue, shortness of breath (dyspnoea) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was hospitalized 2 months 9 days after this event occurred. The event fatigue and dyspnoea were assessed as medically significant.  On 12-Nov-2020, the patient was admitted to the hospital where he was diagnosed with serious multiple pneumonias caused by a viral interstitial infection (pneumonia viral) 2 months 8 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.   The patient was hospitalized for all the events in the intensive care unit.  It was reported that patient was on a ventilator but after diagnosed with multiple pneumonias ventilator has since been taken off.  The caller reported that the consumer is still in the hospital.  Reporter relationship : Caregiver, Product used : Used. Still using product : No.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The patient was not recovered from any of the event at the time of reporting.; Sender's Comments: This case concerns a 77-years-old male patient who experienced viral pneumonia, fatigue, dyspnoea, back pain and pain in extremity after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. Further information regarding medical history, concomitant medications, previous vaccination and laboratory data ruling out predisposing etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Pneumonia viral
Clinical narrative: multiple pneumonias caused by an viral interstitial infection; fatigue; Shortness of breath; back pain; pain in the left arm and hand; Initial information was received on 16-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health professional.   This case involves a 77-years-old male patient who experienced multiple pneumonias caused by a viral interstitial infection (pneumonia viral), fatigue, shortness of breath (dyspnoea), back pain and pain in the left arm and hand (pain in extremity), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 04-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE injection (lot number: UJ444AA, expiry date- 30-Jun-2021, strength: standard) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 04-Sep-2020, the patient developed serious back pain, pain in the left arm and hand (pain in extremity), fatigue, shortness of breath (dyspnoea) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was hospitalized 2 months 9 days after this event occurred. The event fatigue and dyspnoea were assessed as medically significant.  On 12-Nov-2020, the patient was admitted to the hospital where he was diagnosed with serious multiple pneumonias caused by a viral interstitial infection (pneumonia viral) 2 months 8 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.   The patient was hospitalized for all the events in the intensive care unit.  It was reported that patient was on a ventilator but after diagnosed with multiple pneumonias ventilator has since been taken off.  The caller reported that the consumer is still in the hospital.  Reporter relationship : Caregiver, Product used : Used. Still using product : No.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The patient was not recovered from any of the event at the time of reporting.; Sender's Comments: This case concerns a 77-years-old male patient who experienced viral pneumonia, fatigue, dyspnoea, back pain and pain in extremity after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. Further information regarding medical history, concomitant medications, previous vaccination and laboratory data ruling out predisposing etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Burning sensation, Myalgia, Pain
Clinical narrative: Stage 4 prostate cancer; toothache; leg pain/arm pain; left ankle; burning; muscle pain; body aches; weakness; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional via Medical Information (Reference number- US-SANOFI-00365438) and transmitted to Sanofi on 19-Nov-2020.  This case involves a 80 year old male patient who had stage 4 prostate cancer (prostate cancer), body aches (pain), toothache (toothache), leg pain/arm pain (pain in extremity), muscle pain (myalgia), weakness (asthenia), left ankle (arthralgia) and burning (burning sensation), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Patient had a shingles shot some years back and he was in terrible pain in all of his teeth and it felt like 15 root canals for a year.   On 13-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious stage 4 prostate cancer (prostate cancer) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious body aches (pain), toothache (toothache), leg pain/arm pain (pain in extremity), left ankle (arthralgia) and burning (burning sensation), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  On an unknown date, the patient developed a non-serious muscle pain (myalgia), weakness(asthenia)(2 day),while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  Information on lot number was requested for this case.; Sender's Comments: This case concerns 80 year old male patient who had prostate cancer, pain, toothache, pain in extremity, myalgia, asthenia, arthralgia, burning sensation after vaccination with FLUZONE QIV. The time to onset is compatible. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine can not be assessed.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Prostate cancer stage IV, Toothache
Clinical narrative: Stage 4 prostate cancer; toothache; leg pain/arm pain; left ankle; burning; muscle pain; body aches; weakness; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional via Medical Information (Reference number- US-SANOFI-00365438) and transmitted to Sanofi on 19-Nov-2020.  This case involves a 80 year old male patient who had stage 4 prostate cancer (prostate cancer), body aches (pain), toothache (toothache), leg pain/arm pain (pain in extremity), muscle pain (myalgia), weakness (asthenia), left ankle (arthralgia) and burning (burning sensation), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Patient had a shingles shot some years back and he was in terrible pain in all of his teeth and it felt like 15 root canals for a year.   On 13-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious stage 4 prostate cancer (prostate cancer) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious body aches (pain), toothache (toothache), leg pain/arm pain (pain in extremity), left ankle (arthralgia) and burning (burning sensation), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  On an unknown date, the patient developed a non-serious muscle pain (myalgia), weakness(asthenia)(2 day),while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  Information on lot number was requested for this case.; Sender's Comments: This case concerns 80 year old male patient who had prostate cancer, pain, toothache, pain in extremity, myalgia, asthenia, arthralgia, burning sensation after vaccination with FLUZONE QIV. The time to onset is compatible. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine can not be assessed.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: After I rec the 2nd dose of the vaccine the injection site started getting itchy, Around sat and sun itching increased and the area  became hot to touch swollen and a red ring formed around the injection site the size of a golf ball. I went to the ER this morning and they told me I had an allergic reaction but it was minor. Prescribed prednisone.  Still in pain and can feel the area is still very hot and its itchy
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Muscle spasms
Clinical narrative: I don't know exactly which influenza vaccine was administered, although it was an injection.  I had the vaccination late afternoon on Friday November 13th.  On Monday morning, mid-morning, I started having very serious back spasms. They were strong and extremely painful and lasted about 3 days. I cannot think of anything I did that could have caused the back spasms and I have never experienced anything like them ever before or since. Therefore, I suspect the terrible back spasms were caused by the flu vaccination.  I am a scientist, and while I realize this might not have been caused by the vaccine, I felt it was important to report this severe pain I experienced several days after being vaccinated, lasting several days, and with no other known potential cause.