chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: 8 year old female patient who was given an expired dose of IPOL vaccine, with no reported adverse event; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via other healthcare professional and non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00829525).  This case involves an 8 year old female patient who received expired dose of suspect IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A) for prophylactic vaccination.  On 09-Oct-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot R1F973M and expiry date: 03-Oct-2021) (Frequency: once) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Nurse Practitioner states a dad just called and said his child was given an expired IPOL. Caller wants to know how soon she can get another one. Additional Description of event adverse events: Patient Information patient age less than year enter as 2 month, 4 month. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for Tuberculosis (TB) skin test 0.5ml o Strength standard except for Fluzone HD (high dose), standard. If baby was delivered: delivery date and if baby experienced an adverse event. Inform that they will be receiving a follow up questionnaire. If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is a requirement".   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: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Device connection issue, Needle issue, No adverse event, Underdose
Clinical narrative: A patient received a partial dose of FLUZONE QUADRIVALENT HIGH DOSE due to the vaccine leaking no AE; vaccine leaking out from between the needle and the connection tip on the syringe no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via a consumer/non-health care professional via Medical Information  (Reference number- 00829551) and transmitted to Sanofi on 26-Oct-2021 a specific country.  This case involves a 66 year old female patient who had received a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] due to the vaccine leaking from between the needle and the connection tip on the syringe (underdose and syringe issue).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no concomitant vaccination.   On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ709AA, expiry: 30-Jun-2022, formulation: prefilled syringe) via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication due to Underdose and Syringe leak (latency same day).  It was reported "Pharmacist says that while a technician was administering a dose of FLUZONE high dose (HD) some of the medication leaked around the needle. Caller wants to know if they need to re-administer the medication to the patient. A Pharmacist reporting on behalf of a consumer getting a partial dose of FLUZONE QUADRIVALENT HIGH DOSE due to the vaccine leaking out from between the needle and the connection tip on the syringe. Pharmacist reported that the consumer may have received half of the dose."  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.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was administered Menactra that had expired /no AE; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Medical Information (MI) (Reference number- 00829553).  This case involves a 13-year-old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that had expired (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE, HPV VACCINE VLP RL1 9V (YEAST), and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Prophylactic vaccination.  On 26-Oct-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6691AA and expiry date: 21-Oct-2021) via an unknown route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Nurse is looking for information that they should inform to the patient, as well as if they need to re-vaccinate."  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: 87.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error
Clinical narrative: 8 patients received expired vaccine with no AE; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from other healthcare professional via call center via  Medical Information  (Reference number- 00829571) in a specific country.  This case involves an 87-year-old male patient who received expired vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ515AA and expiry date: 30-Jun-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is."  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: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: FLUZONE HD vaccine from last year, which expired with no reported adverse event; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 89-year-old male patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which  was expired (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ515AA, expiry date:30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual case of medication error due to expired vaccine used (latency: same day)  It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is."  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. 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: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: FLUZONE HD vaccine from last year, which expired on 30-Jun-2021 was given with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via  Medical Information  (Reference number- 00829584) and transmitted to Sanofi on 27-Oct-2021 in a specific country.  This case involves an 88-year-old female patient who vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from last year [Batch number: UJ515AA and expiry date: 30-Jun-2021] (expired product administered).  The patient, medical treatment(s), vaccination(s), and family history were not provided.  No other concomitant vaccines were reported.    On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ515AA and expiry date: 30-Jun-2021] via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired product administered [Latency: on the the same day].  At time of reporting, the outcome was unknown for the event.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 97.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: FLUZONE HD vaccine from last year, which expired on 30JUN2021 with no reported adverse event; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a nurse. This case involves a 97-year-old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was expired (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ515AA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual case of medication error due to expired vaccine used (latency: same day)  It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is."  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. 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: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: FLUZONE HD vaccine from last year, which expired with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a nurse via  Medical Information  (Reference number- 00829588) and transmitted to Sanofi on 27-Oct-2021 in a specific country.  This case is linked to case 2021SA359222 (CLUSTER).  This case involves an 85-year-old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 26-Oct-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Suspension for injection in pre-filled syringe, lot UJ515AA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is."  At time of reporting, no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: FLUZONE HD vaccine from last year, which expired on 30JUN2021 given to patient with no AE; Initial information received on 27-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional via number: 00829590.  This case involves a 87 years old female patient who was administered an expired dose of  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (expired product administered).   The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On 26-Oct-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ515AA and expiry date: 30-JUN-2021) via intramuscular route in  in the left deltoid for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (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 the Directive 2001/83/EC and Module VI. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: patient was inadvertently given an expired dose of Pentacel, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician, other healthcare professional and consumer/non-health care professional via Medical Information (MI) (Reference number- 00830643) and transmitted to Sanofi on 27-Oct-2021.  This case involved a two-month-old (2 months and 3 days) male patient who was inadvertently given an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [Expired product administered].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 27-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ393AA, expiry date: 12-OCT-2021, formulation: suspension for injection) via intramuscular route in the thigh NOS (not otherwise specified) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Nurse reported that a patient was inadvertently given an expired dose of Pentacel, today. She requested guidance on how to proceed."  No other adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or was to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Wrong product administered
Clinical narrative: received fluzone quadrivalent rather than fluzone high dose with no reported adverse event; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional via Regulatory Authority (under the reference 00830730).  This case involves a 77-year-old female patient received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] rather than INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported "Caller states a patient female age 77 received FLUZONE QUADRIVALENT rather than FLUZONE HIGH DOSE; caller would like to know if FLUZONE HIGH DOSE should be administered or if the FLUZONE QUADRAVALENT is suitable."  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.  There will be no information available on the batch number for this case.
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired fluzone high dose was administered to a patient with no reported adverse event; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from other health care professional, non-healthcare professional and physician via GMI (Global Medical Information- 00830761).  This case involves a 83-years 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 medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 26-Oct-2021, the patient received 0.7ml {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ482AA and expiry date 31-Jun-2021 was reported) via intramuscular route in the left deltoid 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 by the regulatory authority. 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: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received FLUBLOK QUADRIVALENT with no adverse event; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Agency (under the reference 00831032).  This case involves a 9 years old patient (unknown gender) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUBLOK QIV (lot QSAA2111 and expiration date: 30-JUN-2022) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual a medication error due to Inappropriate age at vaccine administration (same day latency).  It was reported "Pharmacist asks for information on re-administration of influenza vaccine after a pediatric patient received FLUBLOK QUADRIVALENT."  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: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: extra dose of Menactra administered in error, as a booster dose was not indicated due to receipt of a first Menactra dose by this patient with no reported adverse.; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Medical Information (MI) (Reference number- 00831432) and transmitted to Sanofi on 27-Oct-2021.  This case involves a 12-year-old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 27-Oct-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7190AA, expiry date: 16-Jan-2023) via an unknown route in the left arm for prophylactic vaccination.  It was an actual medication error due to extra dose administered (latency: same day).   It was reported "A 12 year old patient received a dose of Menactra today, 27Oct2021, in error, as a booster dose was not indicated due to receipt of a first Menactra dose by this patient in 2019."  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: F
Vaccine: UNK
Symptoms: Burning sensation, Electric shock sensation, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Soreness; Electrical shocks throughout her body; Pain in both hands with tingling and burning; Pain in both hands with tingling and burning; Pain in both hands with tingling and burning; This spontaneous case was received on 05-Oct-2021 from other non-health professional (consumer)(reference number: SEQW21-03331) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.  On 23-Sep-2020, 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: intramuscular and anatomical location: left arm) for influenza prophylaxis. The batch number reported was 279785 and expiry date was 18-May-2021. The patient did not have an immediate reaction, as reported.  On an unspecified date in 2020, reported as after a week or two after receiving Fluad Quadrivalent, the patient experienced soreness and electrical shocks throughout her body. Within a month she had pain in both hands with tingling and burning. She thought this could be arthritis and now this has spread through her whole body. The patient will be seeing a neurologist tomorrow.   At the time of initial reporting on 05-Oct-2021, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  Company comment: A patient of an unreported age experienced pain and electric shock sensation throughout body, burning sensation, pain, and paraesthesia in both hands after vaccination with the suspect product Fluad Quadrivalent. Due to lack of information regarding patient's medical history, diagnostic findings and alternative aetiology, causal role of the suspect vaccine is unassessable.; Sender's Comments: A patient of an unreported age experienced pain and electric shock sensation throughout body, burning sensation, pain, and paraesthesia in both hands after vaccination with the suspect product Fluad Quadrivalent. Due to lack of information regarding patient's medical history, diagnostic findings and alternative aetiology, causal role of the suspect vaccine is unassessable.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site swelling, Lethargy, Lymphadenopathy
Clinical narrative: Swelling of lymph nodes at neck; Slight fatigue and lethargy; Swelling of arm at injection site; Slight fatigue and lethargy; This spontaneous case was received on 07-Oct-2021 from other non-health professional (reference number: SEQW21-03493) and concerned a 66-year-old, female patient.  The patient's medical history and concomitant medications were unknown.  On 05-Oct-2021, at about 14:40 EDT, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration and anatomical location: not reported) for unknown indication. The batch number was not reported.  On 06-Oct-2021, one day after receiving Fluad Tetra and reported about 16:30 EDT, the patient experienced mild symptoms which included swelling of arm at injection site, swelling of lymph nodes at neck and slight fatigue and lethargy. No medical attention was required.  On 07-Oct-2021, the patient recovered from all events.  The reporter assessed these events as related to Fluad Quadrivalent which were reported as mild reaction to vaccine.  The events of lethargy, 'vaccination site swelling', 'lymph nodes cervical swollen' and fatigue were assessed as non-serious.  Company comment: A 66-year-old patient was vaccinated with Fluad Tetra. One day later, the patient experienced vaccination site swelling, swelling of lymph nodes at neck, fatigue and lethargy. Causal role of the suspect vaccine is assessed as possibly related, due to chronological and biological implausibility.; Reporter's Comments: Mild reaction to Fluad Quadrivalent.; Sender's Comments: A 66-year-old patient was vaccinated with Fluad Tetra. One day later, the patient experienced vaccination site swelling, swelling of lymph nodes at neck, fatigue and lethargy. Causal role of the suspect vaccine is assessed as possibly related, due to chronological and biological implausibility.
Age: 90.0
Sex: F
Vaccine: UNK
Symptoms: Aphasia, Arthralgia, Back pain, Dyspnoea, Erythema
Clinical narrative: Slightly short of breath; Unable to speak; Being hot; Sharp pain in the hip/back region; Turned red; Sharp pain in the hip/back region; This spontaneous case was retrieved on 19-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1735569-1), reported by other healthcare professional and concerned a 90-year-old female patient.  The patient's concurrent condition included recently diagnosed cystitis. The patient's concomitant medications included unspecified antibiotics used for cystitis.  On 25-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose reported as one, route of administration: intramuscular and anatomical location: left arm, indication: not reported). The batch number reported was 312832.  On the same date, after receiving Fluad Quadrivalent, the patient turned red and was unable to speak. Speech came back immediately but patient complained of being hot and slightly short of breath. After five minutes she complained of sharp pain in the hip and back region. These symptoms subsided after about 20 minutes. Paramedics did workup and patient went home.  On 25-Sep-2021, the patient recovered from all events.   The reporter did not provide causality assessment.  This case was assessed as non-serious.  Company Comment: A 90-year-old female patient, developed erythema and speech disorder that recovered immediately and complained of being hot and slight shortness of breath, same day after vaccination with the suspect product, Fluad Quadrivalent. The patient developed also, sharp pain in the hip and back region, few minutes after above reported events. More information regarding medical history and concomitant medications is needed. Since no alternative aetilogy was provided for the event speech disorder, causality cannot be excluded and is assessed as possibly related. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.; Sender's Comments: A 90-year-old female patient, developed erythema and speech disorder that recovered immediately and complained of being hot and slight shortness of breath, same day after vaccination with the suspect product, Fluad Quadrivalent. The patient developed also, sharp pain in the hip and back region, few minutes after above reported events. More information regarding medical history and concomitant medications is needed. Since no alternative aetilogy was provided for the event speech disorder, causality cannot be excluded and is assessed as possibly related. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.
Age: 90.0
Sex: F
Vaccine: UNK
Symptoms: Feeling hot
Clinical narrative: Slightly short of breath; Unable to speak; Being hot; Sharp pain in the hip/back region; Turned red; Sharp pain in the hip/back region; This spontaneous case was retrieved on 19-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1735569-1), reported by other healthcare professional and concerned a 90-year-old female patient.  The patient's concurrent condition included recently diagnosed cystitis. The patient's concomitant medications included unspecified antibiotics used for cystitis.  On 25-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose reported as one, route of administration: intramuscular and anatomical location: left arm, indication: not reported). The batch number reported was 312832.  On the same date, after receiving Fluad Quadrivalent, the patient turned red and was unable to speak. Speech came back immediately but patient complained of being hot and slightly short of breath. After five minutes she complained of sharp pain in the hip and back region. These symptoms subsided after about 20 minutes. Paramedics did workup and patient went home.  On 25-Sep-2021, the patient recovered from all events.   The reporter did not provide causality assessment.  This case was assessed as non-serious.  Company Comment: A 90-year-old female patient, developed erythema and speech disorder that recovered immediately and complained of being hot and slight shortness of breath, same day after vaccination with the suspect product, Fluad Quadrivalent. The patient developed also, sharp pain in the hip and back region, few minutes after above reported events. More information regarding medical history and concomitant medications is needed. Since no alternative aetilogy was provided for the event speech disorder, causality cannot be excluded and is assessed as possibly related. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.; Sender's Comments: A 90-year-old female patient, developed erythema and speech disorder that recovered immediately and complained of being hot and slight shortness of breath, same day after vaccination with the suspect product, Fluad Quadrivalent. The patient developed also, sharp pain in the hip and back region, few minutes after above reported events. More information regarding medical history and concomitant medications is needed. Since no alternative aetilogy was provided for the event speech disorder, causality cannot be excluded and is assessed as possibly related. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; Missed 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient herself/himself. The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The patient missed the 2nd dose, which led to incomplete course of vaccination. At the time of reporting, the patient had actual shingles. The patient asked after the recovery from shingles if he/she need to start with the 1st dose again then would make sure to get the 2nd dose. The reporter consented to follow-up.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose to adult pt; adult pt was administered a pediatric dose; This case was reported by a other health professional and described the occurrence of accidental underdose in a 38-year-old female patient who received HBV (Engerix B pediatric) (batch number Lx4xp, expiry date 6th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2021, the patient received the 1st dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 26th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The patient received a pediatric dose of Engerix B by mistake which led to accidental underdose and adult use of a child product. The reporter did not consent to follow-up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: muscle pain; headache; Nausea; chills; feverish; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 25th October 2021 11:00, the patient received the 2nd dose of Shingrix. In October 2021, less than a day after receiving Shingrix, the patient experienced chills and fever. On 25th October 2021 23:00, the patient experienced nausea. On 26th October 2021, the patient experienced muscle pain and headache. On an unknown date, the outcome of the muscle pain, headache and chills were not recovered/not resolved and the outcome of the fever and nausea were unknown.   It was unknown if the reporter considered the muscle pain, headache, chills, fever and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The patient received dose of Shingrix vaccine at his physician's office and felt nauseous before bed at around 11 pm, and was feverish and had chills in the middle of the night. The patient woke up today (on the day of reporting) with a headache, muscle ache and chills. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Half dose administered (0.25 ML); This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 13-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 5277A, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA).   On 20th October 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season .25 ml and Fluarix Tetra Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a clinical supervisor. On 16th September 2021, the patient received 1st dose of Fluarix tetra. The reporter stated that, half dose (0.25 ml) was administered to infant patient, which led to underdose. The reporter consented to follow up. This case is linked to the case US2021222733 and US2021222782, reported by the same reporter. Note: Event outcome date was reported as 26th October 2021 however was not captured considering the nature of event (medication error).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222733:same reporter US-GLAXOSMITHKLINE-US2021222782:same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination were not reported. The nurse reported that the patient received only the liquid component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.; Sender's Comments: This case was reported by a nurse via call center representative and described the occurrence of inappropriate reconstitution technique in a male patient who received Men ACWY-CRM NVS (Menveo) for an unknown indication.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate reconstitution technique. The action taken with Menveo was unknown. On an unknown date, the outcome of the inappropriate reconstitution technique was unknown.   It was unknown if the reporter considered the inappropriate reconstitution technique to be related to Menveo.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: HAD ISSUES  FROM COVID SHOT; This spontaneous report received from a patient concerned a 76 year old female of unspecified race and ethnicity The patient's weight was 60.5 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported administered 1 total for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included Epoprostenol sodium. On an unspecified date, the patient experienced had issues from Covid shot, and was hospitalized on 25-OCT-2021. It was reported that the patient was still hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had issues from Covid shot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20211100399-Covid-19 vaccine ad26.cov2.s - had issues from Covid shot. This event(s) is considered un-assessable. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH FROM JANSSEN VACCINE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was happy and enjoying life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 25-OCT-2021, the patient experienced death from janssen vaccine. On 25-OCT-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211103989.; Sender's Comments: V0: 20211102972-JANSSEN COVID-19 VACCINE Ad26.COV2.S- DEATH. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH