chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received possible expired dose  of vaccine with no reported adverse event; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional [ -00797024].  This case involves a female patient of unknown age who was vaccinated with expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Expired product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 mL (total) dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength: standard; lot QFAA2007 and expiry date 23-May-2021) via an unknown route at an unknown administration site prophylactic vaccination.  It was reported "Caller was given the Vaccine with expiration date of 05/19/2021. Caller wanted to see if someone could make sure this was the correct expiration date for the product. Outbound call placed to Pasteur CS on 04Oct2021. Verified with Pasteur CS the date of expiry date 23-Ma-2021 upon looking up the given".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was administered with a PENTACEL vaccine which was not reconstitute with the liquid portion with no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00797394) and transmitted to Sanofi on 04-Oct-2021.  This case involves a patient (unknown demographics) who was administered with a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which was not reconstituted with the liquid portion (product preparation issue).  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 DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).   It was reported "Vaccine specialist states her customer reported a misuse of PENTACEL, states that the customer did not reconstitute the vaccine and only the liquid portion of PENTACEL was administered to the patient. Vaccine specialist states customer had tried calling last week and was told that they would receive a call back to discuss recommendations following misuse of PENTACL, but they have not received call back. Vaccine specialist asks if this agent can call her customer."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 16.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of IPOL was administered to one patient today with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00798411) and transmitted to Sanofi on 05-Oct-2021.  This case involves a 16-year-old male patient who vaccinated with fourth 0.5 mL (once) dose of expired IPV (VERO) [IPOL] (lot R1F973M, expiry date 03-Oct-2021) via intramuscular route in the right deltoid on 05-Oct-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, past vaccination and family history were not provided.  Concomitant medications included HPV VACCINE and MENINGOCOCCAL VACCINE for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 8.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Ipol was administered to patient on 04Oct2021 but the product had an expiration date of 03Oct2021 with no reported adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from nurse, physician and consumer/ non healthcare professional. This case involves a 8 years old male patient who received POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) on 04-Oct-2021 but the product had an expiration date of 03-Oct-2021 (expired product administered).  No other vaccines were administered to the patient.  The medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 04-Oct-2021, the patient received a 0.5 mL fifth dose of suspect IPOL (Total, lot R1F97 and expiration date: 03-Oct-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Caller requests information on administering expired product."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Medication error
Clinical narrative: received FLUZONE QIV NP vaccinations from single-dose vials that had expired with no adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Media Information (under the reference 00798634).  This case involves ten patients (unknown age and gender) who had received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] from single-dose vials that had expired (expired product administered).  The patients' past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Oct-2021, the patients received a dose of suspect INFLUENZA QUADRIVAL (0.5 ml, single dose vial, lot U7045DA and expiration date: 30-Jun-2021) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine administered (same day latency).  It was reported "Caller states that ten employees at her facility received FLUZONE QIV NP vaccinations on 01OCT2021 from single-dose vials that had expired on 30JUN2021. Caller asked whether or not those doses counted or if the employees should be revaccinated."  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: a patient was inadvertently given a dose of Act-Hib, reconstituted with sterile water/no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (MI) (Reference number- 00798637) and transmitted to Sanofi on 05-Oct-2021.   This case involves a 7 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] which was inadvertently reconstituted with sterile water.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); POLIO VACCINE INACT (IPV); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 27-Sep-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UJ545AA, expiry date-22-Jul-22 via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product preparation error (latency same day).  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received MENACTRA vaccine after approximately 2 years of receiving Meningococcal vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (MI) (Reference number- 00798730) and transmitted to Sanofi on 05-Oct-2021.  This case involves a 44-year-old male patient who was received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] after approximately 2 years of receiving MENINGOCOCCAL VACCINE (Inappropriate schedule of product administration).  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 MENINGOCOCCAL VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.   On 05-Oct-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate schedule of vaccine administered (latency same day).  It was reported "Patient received MENACTRA on 05Oct2021, but after leaving he realized he had received a Meningococcal vaccine approximately 2 years ago. Caller states according to regulatory authority, boosters for MENACTRA should only be administered every 4 years and is wanting to find more information in regards to this. He is asking for any problems associated with this"  No other adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient recived expired dose of vaccine with no reported adverse event; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via (Medical Information- 00798747).  This case involves 63 years 10 months -old female patient who was vaccinated with expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 04-Oct-2021, the patient received a 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number R1F78 and expiry date 30-Sep-2021 was reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in guidelines. 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: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: dose of polio vaccine was given that was 1 week expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Nurse  This case involves a 44-year-old female patient who vaccinated with a 0.5 mL (total, once) dose of IPV (VERO) [IPOL] that was later noted to have 1 week expired (lot R1F801M, expiry date 20-Sep-2021) via intramuscular route in the left deltoid on 05-Oct-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient received an ACTHIB vaccine in the office that had expired with no reported adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from an other health professional via Media Information (under the reference 00799026).  This case involves a 1 years old male patient who received an HIB (PRP/T) VACCINE [ACT-HIB] vaccine in the office that had expired (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 05-Oct-2021, the patient received a dose of suspect ACT-HIB (0.5 ml, total, Once Frequency-1X, lot UJ404AAB and expiration date: 04-oct-2021) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine administered (same day latency).  It was reported "Caller states that a patient received an ACTHIB vaccine in the office on 05OCT2021 that had expired on 04OCT2021 and wanted to know how soon the patient could be revaccinated. Caller states that only 1 patient received expired ACTHIB and requested that information on expired products be emailed to her."  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: dose of ACT-HIB was given to a patient, and realized afterwards it was expired with no reported AE; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from other-health care professional and physician and consumer via [medical information (MI) - 00799417].  This case involves 14 months old male patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX DTP) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), for prophylactic vaccination.   On 05-Oct-2021, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (total, lot number: UJ399AAC and expiry date 02-Oct-2021) via unknown route in the leg, for prophylactic vaccination.  It was reported "office manager states a dose of ACT-HIB (095 - ACT-HIB) was given to a patient, and realized afterwards it was expired. Vaccine expired on 02Oct2021. Looking for information in regards to any side effects to look out for, as well as if they need to re-vaccinate. A dose of ActHIB was administered to a patient in the leg. The Medical Assistant was attempting to enter the dose in the electronic medical record when the system rejected the dose because it expired on 02Oct2021. It was then that it was realized that an expired dose was administered to the patient. The caller is not able to see in the record which leg was used for the injection site, since the system would not allow the dose to be recorded".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUA4
Symptoms: Accidental exposure to product, Exposure via eye contact, Occupational exposure to product, Ocular discomfort, Syringe issue
Clinical narrative: Uncomfortable in the first minutes after drop of the vaccine went into the pharmacy technician eye; A small drop of the vaccine went into the pharmacy technician's eye after removing the cap; Leaking syringe after cap removal (there was no signs of damage on the syringe or needle); This spontaneous case was received on 24-Sep-2021 from a pharmacist via Agency (reference number: SEQW21-02751) with additional information received on 05-Oct-2021 from Agency (being processed together) and concerned a female pharmacy technician of an unspecified age.   The pharmacy technician had no relevant medical history and was not taking any concomitant medications.   On 24-Sep-2021, after the pharmacy technician removed the cap (lid) of the 0.5 ml pre-filled syringe (PFS) Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59) a small drop of the vaccine went into the pharmacy technician's eye (explicitly coded as 'Occupational exposure while administering product') and the syringe leaked (explicitly coded as 'Product leakage'). The batch number reported was 312828 and expiry date was 23-Apr-2022. No signs of damage on the syringe or needle were noted. As reported, the defect was related to Fluad Quadrivalent cap removal.  In the first minutes after drop of the vaccine went into the pharmacy technician eye, the pharmacy technician felt uncomfortable. No other side effects were reported. No corrective treatment was applied.  On the same day, the pharmacy technician recovered from the event of 'discomfort'.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company Comment: A small drop of the suspect vaccine Fluad Quadrivalent went into the pharmacy technician's eye after removing the cap. As reported the syringe leaked. Causality for occupational exposure to product and product leakage is assessed as not related as per company specific guidelines. As reported the pharmacy technician felt uncomfortable. Causality for the event discomfort is assessed as not related due to biological implausibility.; Sender's Comments: A small drop of the suspect vaccine Fluad Quadrivalent went into the pharmacy technician's eye after removing the cap. As reported the syringe leaked. Causality for occupational exposure to product and product leakage is assessed as not related as per company specific guidelines. As reported the pharmacy technician felt uncomfortable. Causality for the event discomfort is assessed as not related due to biological implausibility.
Age: 22.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site reaction with redness and swelling; Site reaction with redness and swelling; This spontaneous case was received on 27-Sep-2021 from other health professional via Communications (reference number: SEQW21-02807) and concerned a 22-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.   On 20-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 38518 and expiry date 30-Jun-2022.    On the same day, after receiving Flucelvax Quadrivalent, the patient experienced moderate to severe site reaction with redness and swelling. The patient was treated with unspecified antibiotics.  On an unspecified date in Sep-2021, the patient recovered from both events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  The case is linked to 202103208 and 202103209 due to same reporter.   Company comment: The events of 'vaccination site erythema' and 'vaccination site swelling' were assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events of 'vaccination site erythema' and 'vaccination site swelling' were assessed as related to Flucelvax Quadrivalent.
Age: 21.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site reaction with redness and swelling; Site reaction with redness and swelling; This spontaneous case was received on 27-Sep-2021 from other health professional via Communications (reference number: SEQW21-02807) and concerned a 21-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 20-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 38518 and expiry date 30-Jun-2022.    On the same day, after receiving Flucelvax Quadrivalent, the patient experienced moderate to severe site reaction with redness and swelling.  On an unknown date, the patient was treated with unspecified antibiotics.  On an unspecified date in Sep-2021, the patient recovered from both events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  This case is linked to cases 202103207 and 2021103209 due to same reporter.  Company comment: The events of 'vaccination site erythema' and 'vaccination site swelling' were assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events of 'vaccination site erythema' and 'vaccination site swelling' were assessed as related to Flucelvax Quadrivalent.
Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: Site reaction with redness and swelling; Site reaction with redness and swelling; Nausea; Pain; This spontaneous case was received on 27-Sep-2021 from other health professional via Communications (reference number: SEQW21-02807) and concerned a 46-year-old, female patient.  The patient had no relevant medical history. The patient's concomitant medications included Atorvastatin (atorvastatin calcium) and Zebeta (bisoprolol fumarate), both used for an unreported indication.  On 20-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 38518 and expiry date 30-Jun-2022.    On the same day, after receiving Flucelvax Quadrivalent, the patient experienced moderate to severe site reaction with redness and swelling.  On an unspecified date in Sep-2021, the patient experienced nausea and pain. She went to urgent care to treat symptoms. It was also reported that patient was treated with unspecified antibiotics.  The outcome for all events was not reported.   The reporter did not provide causality assessment.  The case was assessed as non-serious.  The case is linked to 202103207 and 202103208 (due to same reporter).  Company comment: A 46-year-old, female patient developed vaccination site swelling and erythema on the same day after vaccination with the suspect product Flucelvax Quadrivalent. On an unspecified date within the same month the patient experienced nausea and pain. Information regarding the related diagnostic findings have not been provided, although the patient started treatment with unspecified antibiotics. Based on provided information causality for the events vaccination site swelling and erythema is assessed as possibly related. Due to unclear chronology, causality for all other events is unassessable. Limited information precludes assessment of Brighton Collaboration criteria for cellulitis.; Sender's Comments: A 46-year-old, female patient developed vaccination site swelling and erythema on the same day after vaccination with the suspect product Flucelvax Quadrivalent. On an unspecified date within the same month the patient experienced nausea and pain. Information regarding the related diagnostic findings have not been provided, although the patient started treatment with unspecified antibiotics. Based on provided information causality for the events vaccination site swelling and erythema is assessed as possibly related. Due to unclear chronology, causality for all other events is unassessable. Limited information precludes assessment of Brighton Collaboration criteria for cellulitis.
Sex: F
Vaccine: UNK
Symptoms: Erythema, Feeling hot
Clinical narrative: Arm became hot and red; Arm became hot and red; This spontaneous case was received on 27-Sep-2021 from other health professional via  Communications (reference number: SEQW21-02839) and concerned a female patient, of an unknown age.   The patient's relevant medical history and concomitant medications were not reported.   On 22-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration and anatomical location: not reported) as prevention of seasonal influenza. The batch number reported was 312852 and expiry date 17-Jun-2022.    On the same day, after receiving Fluad Quadrivalent, the patient experienced an adverse site reaction as her arm became hot and red.  The outcome of the events was unknown.   The reporter assessed the events to be related to Fluad Quadrivalent.  The case is linked to cases 202103211 and 202103212 (the same reporter).  Company comment: A patient of an unknown age received Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient's arm became hot and red. Causal role of the suspect vaccine is assessed as possibly related.; Reporter's Comments: The reporter assessed the events to be related to Fluad Quadrivalent, as it was stated the patient experienced an adverse site reaction.; Sender's Comments: A patient of an unknown age received Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient's arm became hot and red. Causal role of the suspect vaccine is assessed as possibly related.
Sex: F
Vaccine: UNK
Symptoms: Erythema, Feeling hot
Clinical narrative: Arm became hot and red; Arm became hot and red; This spontaneous case was received on 27-Sep-2021 from other health professional via Med Communications (reference number: SEQW21-02839) and concerned a female patient, of an unreported age.   The patient's relevant medical history and concomitant medications were not reported.   On 20-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration and anatomical location: not reported) as prevention of seasonal influenza. The batch number reported was 312852 and expiry date: 17-Jun-2022.    On the same day, after receiving Fluad Quadrivalent, the patient experienced an adverse site reaction as her arm became hot and red.  The outcome of the events was unknown.   The reporter assessed the events as related to Fluad Quadrivalent.   The case is linked to cases 202103210 and 202103212 (same reporter).  Company comment: A patient of an unknown age received Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient's arm became hot and red. Causal role of the suspect vaccine is assessed as possibly related.; Reporter's Comments: The reporter assessed the events as related to Fluad Quadrivalent as it was stated that the patient experienced advirse site reaction.; Sender's Comments: A patient of an unknown age received Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient's arm became hot and red. Causal role of the suspect vaccine is assessed as possibly related.
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Arm became hot and red; Arm became hot and red; This spontaneous case was received on 27-Sep-2021 from other health professional via  Communications (reference number: SEQW21-02839) and concerned a female patient, of an unknown age.   The patient's relevant medical history and concomitant medications were not reported.   On 23-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration and anatomical location: not reported) as prevention of seasonal influenza. The batch number reported was 312852 and expiry date 17-Jun-2022.    On the same day, after receiving Fluad Quadrivalent, the patient experienced an adverse site reaction as her arm became hot and red.  The outcome of the events was unknown.  The reporter assessed the events to be related to Fluad Quadrivalent.  The case is linked to cases 202103210 and 202103211 (the same reporter).  Company comment: A patient of an unknown age received Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient's arm became hot and red. Causal role of the suspect vaccine is assessed as possibly related.; Reporter's Comments: The reporter assessed the events to be related to Fluad Quadrivalent, as it was stated the patient experienced an adverse site reaction.; Sender's Comments: A patient of an unknown age received Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient's arm became hot and red. Causal role of the suspect vaccine is assessed as possibly related.
Sex: F
Vaccine: FLUC3
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Sore arm; Aches; Fatigue; This spontaneous case was received on 28-Sep-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-02897) and concerned a female patient of an unreported age. At the time of this report, the patient was 67-year-old.  The patient's medical history was not reported. The patient's concomitant medication included Metoprolol (metoprolol tartrate) used for an unreported indication.  On an unspecified date in 2019, two years ago as reported, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, anatomical location and route of administration: not reported) for prevention of seasonal influenza. The batch number was not reported.  On an unspecified date in 2019, unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced sore arm, mild aches and fatigue.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  Company comment: A female patient, of an unreported age was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced sore arm, mild aches and fatigue. Causal role of the suspect vaccine is unassessabe for all events, due to unclear temporal relationship.; Sender's Comments: A female patient, of an unreported age was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced sore arm, mild aches and fatigue. Causal role of the suspect vaccine is unassessabe for all events, due to unclear temporal relationship.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash papular
Clinical narrative: Rash on the same arm the vaccine was administered (left arm) that was raised red bumps from the elbow to the hand; Rash on the same arm the vaccine was administered (left arm) that was raised red bumps from the elbow to the hand; This spontaneous case was received on 29-Sep-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-02995) and concerned a 51-year-old, female patient.   The patient's concurrent conditions included allergy to Compazine (prochlorperazine edisylate) and allergy to penicillin. The patient's concomitant medication included Bupropion (bupropion hydrochloride), Dexilant (dexlansoprazole), Nasonex (mometasone furoate) and Shingrix (varicella zoster vaccine rgE (CHO)) administered on an unspecified date in 2021 ('couple of weeks before' as reported), all used for an unreported indication.  On 28-Sep-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location: left arm, dose and route of administration: not reported) to prevent influenza. The batch number reported was P100354284, expiry date: 14-Jun-2022.   On the same day, two hours after receiving Afluria Quadrivalent, the patient experienced rash on the same arm the vaccine was administered (left arm). The rash was raised red bumps from the elbow to the hand.  At the time of initial report on 29-Sep-2021, the patient had not recovered from the events.  The reporter did not provide a causality assessment to Afluria Quadrivalent.   This case was assessed as non-serious.  Company comment: Events of 'raised rash' and 'red rash' are assessed as related to Afluria Quadrivalent.; Sender's Comments: Events of 'raised rash' and 'red rash' are assessed as related to Afluria Quadrivalent.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: An anaphylactic reaction to flu vaccine, probably the thimerosal; This spontaneous case was received on 30-Sep-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-03068) and concerned a 40-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On an unspecified date in 1996, reported as 25 years ago, the patient was vaccinated with influenza virus vaccine polyvalent (brand unspecified; dose, route of administration and anatomical location: not reported) as an influenza prophylaxis. The batch number was not reported.  On an unspecified date in 1996, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to flu vaccine, probably to the thimerosal.   The outcome of the event was not reported.  The reporter assessed the event of anaphylactic reaction to vaccine to be related to influenza virus vaccine polyvalent. As reported, the patient had an anaphylactic reaction to flu vaccine, and she had not had a flu vaccine in 25 years because of the reaction.  The events of 'anaphylactic reaction to vaccine' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 40-year-old patient was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient experienced anaphylactic reaction. Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship.; Reporter's Comments: As reported, the patient had an anaphylactic reaction to flu vaccine, and she had not had a flu vaccine in 25 years because of the reaction.; Sender's Comments: A 40-year-old patient was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient experienced anaphylactic reaction. Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship.
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Contusion, Incorrect route of product administration
Clinical narrative: Got a bruise; Patient had received Fluad Quad via subcutaneous instead of intramuscular; This spontaneous case was received on 30-Sep-2021 from a pharmacist via Med Communications (reference number: SEQW21-03009) with an additional information received on the same day (being processed together) and concerned a 68-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 30-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: subcutaneous and anatomical location: not reported) (explicitly coded as 'Inappropriate route of vaccination') for influenza prophylaxis. The batch number reported was 312848 and expiry date was 08-Jun-2022.  On the same day, after receiving Fluad Quadrivalent, the patient developed a bruise. The patient did not receive any corrective treatment for the event.  The outcome of the event of bruise was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company Comment: A 68-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent through an inappropriate route of vaccination. As reported the patient developed on the same day a bruise. Causality for inappropriate route of vaccination is assessed as not related as per company specific guidelines. Causality for the event bruise is assessed as possibly related although confounded by inappropriate route of administration.; Sender's Comments: A 68-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent through an inappropriate route of vaccination. As reported the patient developed on the same day a bruise. Causality for inappropriate route of vaccination is assessed as not related as per company specific guidelines. Causality for the event bruise is assessed as possibly related although confounded by inappropriate route of administration.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram head normal, Endotracheal intubation, Enterovirus test positive, Facial bones fracture
Clinical narrative: He reported weakness ever since the vaccine.  He now reportedly required a walker to get around.  He became weaker to the point of suffer a fall 9/26, 3 days after vaccine and was hospitalized with trauma and nasal fracture.  Also found to have tested + for rhino/enterovirus.  Subsequently discharged to swing bed and readmitted on October 8 with new onset SEIZURES, now unresponsive and intubated on vent support.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Human rhinovirus test positive, Injury, Mechanical ventilation, Seizure
Clinical narrative: He reported weakness ever since the vaccine.  He now reportedly required a walker to get around.  He became weaker to the point of suffer a fall 9/26, 3 days after vaccine and was hospitalized with trauma and nasal fracture.  Also found to have tested + for rhino/enterovirus.  Subsequently discharged to swing bed and readmitted on October 8 with new onset SEIZURES, now unresponsive and intubated on vent support.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Walking aid user
Clinical narrative: He reported weakness ever since the vaccine.  He now reportedly required a walker to get around.  He became weaker to the point of suffer a fall 9/26, 3 days after vaccine and was hospitalized with trauma and nasal fracture.  Also found to have tested + for rhino/enterovirus.  Subsequently discharged to swing bed and readmitted on October 8 with new onset SEIZURES, now unresponsive and intubated on vent support.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Day 7 and 8 after  receiving the vaccine, I felt a type of severe fatigue different than I had ever felt before. Suffered pain (4 on a scale of 1 to 10) in leg muscles and joints.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Chest pain, Condition aggravated, Electrocardiogram
Clinical narrative: Since the third day, every night I felt a hint of chest pain/distress, which becomes more clear during a deep breath, for around 1.5 weeks. It dispear during the day and after 10 days, but reappears indefinitely later. I went to see a cardiologist, and the doctor listened to my heart and lung and said that may be asthma. My asthma was asymptomatic before the vaccination and only appears during extremely hard exercise. After the vaccination I also found my asthma got worse (noticable during long fast walking/slow running, and sometimes at rest).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Peak expiratory flow rate
Clinical narrative: Since the third day, every night I felt a hint of chest pain/distress, which becomes more clear during a deep breath, for around 1.5 weeks. It dispear during the day and after 10 days, but reappears indefinitely later. I went to see a cardiologist, and the doctor listened to my heart and lung and said that may be asthma. My asthma was asymptomatic before the vaccination and only appears during extremely hard exercise. After the vaccination I also found my asthma got worse (noticable during long fast walking/slow running, and sometimes at rest).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Urticaria
Clinical narrative: The day after my shot, I started developing hives. The hives worsened over days and persisted for about 3 months. The hives appeared to come out each evening. I initially consulted my primary care MD who suggested I take Benadryl which I did. It did not help. I then went to an Urgent Care facility and it was suggested I take Allegra during the day and Benadryl at night, which I did. This helped only mildly. I saw an allergist in May and June 2021. Allergy testing was completed. I did not show an allergy to anything. It was doctor's impression that I had an adverse IMMUNE response to the Vaccine.  It is unclear if this response is at all related to my Hashimotos disease which is an auto immune disease.  My bloodwork did show markers for auto-immune disease; however it is possibly a marker  for something in addition to Hashimotos (possibly Lupus). I am scheduled to see a rheumatologist in a few weeks to follow up on this finding.  I continued to take the Allegra and Benadryl through the end of  July 2021/beginning of August. The hives persisted until that time, when they gradually went away.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Electrocardiogram, Insomnia, Lymph node pain
Clinical narrative: Neck pain the day after injection with swelling/lump appeared at base of neck with pain lasting 4 days. Pain in neck changed to swollen lymph nodes is collar bone protruding through collar bone, lymph nodes in breast swollen and painful. Swelling, tightness and burning sensation throughout left upper chest, collar bone, breast, ribs and shoulder blade. Pain and swelling still occurring. Having trouble sleeping due to issues. Have been applying warm compresses to areas and taking over the counter pain meds. Starting to worry that sus tons aren?t subsiding.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain, Swelling
Clinical narrative: Neck pain the day after injection with swelling/lump appeared at base of neck with pain lasting 4 days. Pain in neck changed to swollen lymph nodes is collar bone protruding through collar bone, lymph nodes in breast swollen and painful. Swelling, tightness and burning sensation throughout left upper chest, collar bone, breast, ribs and shoulder blade. Pain and swelling still occurring. Having trouble sleeping due to issues. Have been applying warm compresses to areas and taking over the counter pain meds. Starting to worry that sus tons aren?t subsiding.