chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke after vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient in his 60's (reported as 60-64 years) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke after vaccine". Clinical course: Patient got his first booster and he was sort of throwing strokes. Patient experienced stroke after vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: A little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: EW0173) at the age of 42 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing); "surgery" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION oral taken for attention deficit hyperactivity disorder (ongoing); GUANFACINE oral taken for attention deficit hyperactivity disorder (ongoing). The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "A little tired".  Additional information: No family history of any adverse vaccine events. Vaccine facility type for 1st dose was at Hospital. Vaccine administered at military facility: No. Relevant test: None. Specific relevant test for thromboembolic events with thrombocytopenia: None.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201290827 Same patient/ vaccine, different dose/ AE;US-PFIZER INC-202201290802 Same patient/ vaccine, different dose/ AE;US-PFIZER INC-202201236731 Same patient/ vaccine, different dose/ AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "PT caught COVID after vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "PT caught COVID after vaccine".  Additional information:  Okay. And you probably know now that they want three. They recommend not just a second, now they're recommending a third. So, people with MS should definitely get that, and even though  you've already had COVID once, it doesn't mean you can't have it again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: .; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP),  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I recently contracted the virus and I know without your vaccine, I would not have survived it.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Heart rate increased, Palpitations
Clinical narrative: extreme fatigue; palpitations; Fast heart rate; Initial information was received on 03-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 25 years old female patient who experienced extreme fatigue, palpitations and fast heart rate after receiving vaccine influenza quadrival A-B multidose vaccine preserved [Fluzone].  Pre-existing conditions: Asthma, Attention deficit hyperactivity disorder, Drug hypersensitivity and Food allergy.The patient's past medical history included COVID-19. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included loratadine (Claritin [loratadine]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (adderall) and levosalbutamol hydrochloride (Xopenex) and covid-19 vaccine (covid-19 vaccine) for covid-19 immunization.  On 14-Oct-2022, at 14:45 hours the patient received dose 1 of suspect influenza quadrival A-B multidose vaccine preserved lot GJ375 via unknown route for prophylaxis.   On 17-Oct-2022 at 07:15 hours (latency: 2 days) the patient developed non-serious events of extreme fatigue , palpitations and fast heart rate (heart rate increased) following the administration of influenza quadrival A-B multidose vaccine preserved.  Action taken : Not Applicable.  No corrective treatment was received for the events (extreme fatigue, palpitations, Fast heart rate).  At time of reporting, the outcome was Recovering / Resolving for all the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 06-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves Adult and unknown gender patient who experienced flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In 2009, the patient received suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (strength, form, dose, frequency, expiry date: unknown) for flu.  In 2009 the patient developed a non-serious event of flu (influenza) (latency: same day) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, C-reactive protein increased, Disability, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: unable to complete daily activities; weakness in arms; neck pain; weakness in legs after flying; swelling of hands; whole body pain; whole body pain and weakness; Initial information on 26-Oct-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 73 years old female patient who was unable to complete daily activities, neck pain, weakness in legs after flying, swelling of hands, whole body pain, whole body pain and weakness and weakness in arms while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis.    On 23-Apr-2019, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT at a dose of 0.5 ml (lot U6014AB, expiry date: 20-Jul-2020) via intramuscular route in the left deltoid for immunisation.  On an unknown date the patient developed a serious unable to complete daily activities (loss of personal independence in daily activities) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. This event was leading to disability. On 25-Apr-2019 the patient developed a non-serious neck pain, weakness in legs after flying (muscular weakness), swelling of hands (peripheral swelling), whole body pain (pain), whole body pain and weakness (asthenia), 2 days following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. On an unknown date the patient developed a non-serious weakness in arms (muscular weakness), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Relevant laboratory test results included: C-reactive protein - On an unknown date: [heightened] Red blood cell sedimentation rate - On an unknown date: [heightened] No positive RA test   Action taken: Not applicable.  Steroids as corrective treatment was received for the events.  Outcome: Recovering / Resolving for all the events.; Sender's Comments: Sanofi company comment dated 02-Nov-2022: This case involves a 73 years old female patient who was unable to complete daily activities, neck pain, weakness in legs after flying, swelling of hands, whole body pain, whole body pain and weakness and weakness in arms while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac]. Additional information regarding condition at the time of vaccination, risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Neck pain, Pain, Peripheral swelling, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: unable to complete daily activities; weakness in arms; neck pain; weakness in legs after flying; swelling of hands; whole body pain; whole body pain and weakness; Initial information on 26-Oct-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 73 years old female patient who was unable to complete daily activities, neck pain, weakness in legs after flying, swelling of hands, whole body pain, whole body pain and weakness and weakness in arms while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis.    On 23-Apr-2019, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT at a dose of 0.5 ml (lot U6014AB, expiry date: 20-Jul-2020) via intramuscular route in the left deltoid for immunisation.  On an unknown date the patient developed a serious unable to complete daily activities (loss of personal independence in daily activities) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. This event was leading to disability. On 25-Apr-2019 the patient developed a non-serious neck pain, weakness in legs after flying (muscular weakness), swelling of hands (peripheral swelling), whole body pain (pain), whole body pain and weakness (asthenia), 2 days following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. On an unknown date the patient developed a non-serious weakness in arms (muscular weakness), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Relevant laboratory test results included: C-reactive protein - On an unknown date: [heightened] Red blood cell sedimentation rate - On an unknown date: [heightened] No positive RA test   Action taken: Not applicable.  Steroids as corrective treatment was received for the events.  Outcome: Recovering / Resolving for all the events.; Sender's Comments: Sanofi company comment dated 02-Nov-2022: This case involves a 73 years old female patient who was unable to complete daily activities, neck pain, weakness in legs after flying, swelling of hands, whole body pain, whole body pain and weakness and weakness in arms while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac]. Additional information regarding condition at the time of vaccination, risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 15.0
Sex: F
Vaccine: FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurse gave a flublok vaccine to a 15-year-old with no reported adverse event; Initial information was received on 03-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA461738(CLUSTER).  This case involves 15 years old female patient who experienced nurse gave a influenza quadrivalent recombinant vaccine [Flublok] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2022, the patient received suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 ml once (lot QFAA2231, expiry date - 30-Jun-2023) (form: unknown) via intramuscular route in the left deltoid for Immunization.  On 26-Oct-2022 the patient developed a non-serious event of nurse gave a influenza quadrivalent recombinant vaccine [Flublok] with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken was not applicable.  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: 24.0
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 24 year old was administered Fluzone HD with no adverse event; Initial information received on 03-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 24 years old and unknown gender patient who experienced 24 year old was administered fluzone hd with no adverse event while receiving vaccine Influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine unknown dose, strength, frequency, formulation, lot UT7715AA via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious 24 year old was administered fluzone hd with no adverse event (product administered to patient of inappropriate age) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken with quadrivalent influenza vaccine (fluzone high-dose quadrivalent) was not applicable.  At time of reporting, the outcome was Unknown for the event 24 year old was administered fluzone hd with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient took expired ACTHIB vaccine, with no reported adverse event; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case is linked to case 2022SA460139.  This case involves a 1 years old female patient who took expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.   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); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); and INFLUENZA VACCINE (INFLUENZA) for Immunisation.  On 02-Nov-2022, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (lot UJ600AAB and expiry date: 29-Oct-2022) via intramuscular route in the left thigh for Immunization.  On 02-Nov-2022 (latency: same day), the patient took expired HIB (PRP/T) VACCINE, with no reported adverse event (expired product administered).   It was reported that "A nurse looked at the actual powder component which expires on 30Nov2022. This was realized after the injection."    Action taken: not applicable.  Outcome: 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 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: FLUX
Symptoms: Illness, Malaise
Clinical narrative: usually gets sick after the vaccines; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a female patient of an unknown age who usually gets sick after the vaccines after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, dose, formulation, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event usually gets sick after the vaccines (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: administered only the liquid portion of the pentacel to a patient with no reported adverse event; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who administered only the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE for Immunisation.  On 25-Oct-2022, the patient received a 0.4 ml dose 2 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Frequency: Once) (Strength: Standard) (lot number: U7238AA) (Expiration: 04/May/2023) (formulation unknown) via intramuscular route in the left thigh as Immunization.  On 25-OCT-2022 the patient administered only the liquid portion of the pentacel to a patient with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  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 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: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Medication error, Wrong product administered
Clinical narrative: administration of FLUBLOK instead of FLUZONE HIGH-DOSE QUADRIVALENT to a patient over 65 years of age with no reported AE; FLUBLOK accidentally given instead of FLUZONE HIGH-DOSE QUADRIVALENT to a patient over 65 years of age with no reported AE; Initial information on 07-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/Non-HCP.  This case involves a 66 years old female patient who was administered flublok instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae and flublok accidentally given instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae while receiving vaccine influenza quadrival a-b vaccine [fluzone qiv].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 31-Oct-2022, the patient received a dose of suspect influenza quadrival a-b vaccine (dose- o.5 ml daily (QD), lot UJ893AB via intramuscular route in the left deltoid and expiration date- 09-Jun-2023) (strength and formulation : not reported) as influenza.  On 31-OCT-2022 the patient was administered flublok instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae (wrong product administered) and flublok accidentally given instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae (accidental exposure to product) (latency- same day for both events) following the administration of influenza quadrival a-b vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (administration of FLUBLOK instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae, flublok accidentally given instead of FLUZONE HIGH-DOSE QUADRIVALENT to a patient over 65 years of age with no reported AE).  At time of reporting, the outcome was Unknown for the event administration of flublok instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae and was Unknown for the event flublok accidentally given instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae.  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: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion due to a power outage, normal fridge temperature stays around 41 F, the temperature was 49 F when they discovered the vaccines after the power outage, with no reported adverse event; The FLUZONE HD QIV has been administered post excursion, with no reported adverse event; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 65-year-old male patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] has been administered post excursion and temperature excursion due to a power outage, normal fridge temperature stays around 41 F, the temperature was 49 F when they discovered the vaccines after the power outage, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Nov-2022, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) (lot number: UJ919AD and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for Immunization and it has been administered post excursion, with no reported adverse event (poor quality product administered) (latency: same day) and temperature excursion due to a power outage, normal fridge temperature stays around 41 f, the temperature was 49 f when they discovered the vaccines after the power outage, with no reported adverse event (product storage error.  It was reported, they are not sure what the temperature reached over the weekend. They are not sure if the temperature went any higher than that. They were told that the power was out for approximately 6 hours. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. This situation is reported as a medication error due to the possible inappropriate administration of FLUZONE HD QIV to a patient post excursion.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: TTOX
Symptoms: Anger, Vaccination site erythema, Vaccination site swelling
Clinical narrative: arm of the injection becoming puffed up with getting red and angry; arm of the injection becoming puffed up with getting red and angry; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp.  This case involves elderly female patient who experienced arm of the injection becoming puffed up with getting red and angry while receiving vaccine Tetanus Toxoid.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concurrent condition includes allergies to two types of antibiotics (drug hypersensitivity), allergies to the coating on tablets (allergic reaction to excipient), allergy to yeast (food allergy) and sensitivity to other drugs (drug hypersensitivity).    On an unknown date, the patient received suspect Tetanus Toxoid produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination.  On an unknown onset and latency, the patient developed a non-serious arm of the injection becoming puffed up with getting red and angry (vaccination site erythema and vaccination site swelling).  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for both events.
Age: 58.0
Sex: F
Vaccine: FLUC3
Symptoms: Administration site pain, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Started to feel in the area of the administration redness, warm, pain, tenderness and iduration; Started to feel in the area of the administration redness, warm, pain, tenderness and iduration; Started to feel in the area of the administration redness, warm, pain, tenderness and iduration; Started to feel in the area of the administration redness, warm, pain, tenderness and iduration; This spontaneous case was received on 28-Oct-2022 from a physician assistant via Communications (reference number: SEQW22-05166) and concerned a 58-year-old female patient.  The patient's medical history included rheumatic fever as a child. The patient's concomitant medications were not reported.  On 24-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose reported as '0.5 ml', route of administration: intramuscular (IM), anatomical location: not reported) for prevention of influenza disease. The batch number reported was AS4502A. The expiration date was 30-Jun-2023  On Wednesday, 26-Oct-2022, two days after Flucelvax administration, the patient started to feel in the area of administration redness, warm, pain, tenderness and induration.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 58-year-old female patient experienced vaccination site erythema, vaccination site pain, vaccination site warmth, and vaccination site induration two days following vaccination with Flucelvax Quadrivalent. Causality for the reported events is assessed as probably related due to suggestive temporal relationship and biological plausibility. Per Brighton collaboration criteria, presented information correspond to level 3 diagnostic certainty for cellulitis at injection site.; Sender's Comments: A 58-year-old female patient experienced vaccination site erythema, vaccination site pain, vaccination site warmth, and vaccination site induration two days following vaccination with Flucelvax Quadrivalent. Causality for the reported events is assessed as probably related due to suggestive temporal relationship and biological plausibility. Per Brighton collaboration criteria, presented information correspond to level 3 diagnostic certainty for cellulitis at injection site.
Age: 58.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site warmth
Clinical narrative: Started to feel in the area of the administration redness, warm, pain, tenderness and iduration; Started to feel in the area of the administration redness, warm, pain, tenderness and iduration; Started to feel in the area of the administration redness, warm, pain, tenderness and iduration; Started to feel in the area of the administration redness, warm, pain, tenderness and iduration; This spontaneous case was received on 28-Oct-2022 from a physician assistant via Communications (reference number: SEQW22-05166) and concerned a 58-year-old female patient.  The patient's medical history included rheumatic fever as a child. The patient's concomitant medications were not reported.  On 24-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose reported as '0.5 ml', route of administration: intramuscular (IM), anatomical location: not reported) for prevention of influenza disease. The batch number reported was AS4502A. The expiration date was 30-Jun-2023  On Wednesday, 26-Oct-2022, two days after Flucelvax administration, the patient started to feel in the area of administration redness, warm, pain, tenderness and induration.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 58-year-old female patient experienced vaccination site erythema, vaccination site pain, vaccination site warmth, and vaccination site induration two days following vaccination with Flucelvax Quadrivalent. Causality for the reported events is assessed as probably related due to suggestive temporal relationship and biological plausibility. Per Brighton collaboration criteria, presented information correspond to level 3 diagnostic certainty for cellulitis at injection site.; Sender's Comments: A 58-year-old female patient experienced vaccination site erythema, vaccination site pain, vaccination site warmth, and vaccination site induration two days following vaccination with Flucelvax Quadrivalent. Causality for the reported events is assessed as probably related due to suggestive temporal relationship and biological plausibility. Per Brighton collaboration criteria, presented information correspond to level 3 diagnostic certainty for cellulitis at injection site.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Feeling jittery, Headache, Nervousness, SARS-CoV-2 test negative
Clinical narrative: Severe pain to the Left side of my head, especially my ear, that's where the pain started approximately 2 hours after the vaccine, continued for approximately 24 - 48 hours. Felt "jittery" for 3 days, feeling like I would jump out of my skin.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Hyporesponsive to stimuli, Hypotension, Lethargy, Muscle rigidity
Clinical narrative: Collapsed about 2-3 min after vaccination and had a 30-60 second seizure. The seizure was identified by the vaccination admin, who was also an EMT. He was unresponsive, his eyes were open and fixed looking up and away, his arms were rigid. He tried to sit up after the seizure and he was slow to respond and talk for about 15-20 minutes. He was lethargic for about 60 minutes after the incident. We were seen at the ER by Peds ER docs around noon that day. They consulted with neurology, who considered this a provoked seizure due to vaccination.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Pupil fixed, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Collapsed about 2-3 min after vaccination and had a 30-60 second seizure. The seizure was identified by the vaccination admin, who was also an EMT. He was unresponsive, his eyes were open and fixed looking up and away, his arms were rigid. He tried to sit up after the seizure and he was slow to respond and talk for about 15-20 minutes. He was lethargic for about 60 minutes after the incident. We were seen at the ER by Peds ER docs around noon that day. They consulted with neurology, who considered this a provoked seizure due to vaccination.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness, Dyspnoea, Flushing, Hyperhidrosis
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypersensitivity, Hypotension, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Eye swelling, Hypersensitivity, Mouth swelling, Pharyngeal swelling
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Patient stated and experience throat swelling, white ulcers in back of throat and difficulty breathing in the day following vaccination. She reported she took 2 benadryl and that resolved symptoms.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pharyngeal ulceration, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Patient stated and experience throat swelling, white ulcers in back of throat and difficulty breathing in the day following vaccination. She reported she took 2 benadryl and that resolved symptoms.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Injection site swelling, Mouth swelling, Peripheral swelling, Swelling face
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient went to er after given benedryl and her face and eyes swelled up as well as her arm.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient went to er after given benedryl and her face and eyes swelled up as well as her arm.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient reports severe pain when lifting his arm level with his shoulder.  He went to urgent care and is now having to follow up with a physical therapist.  It has been 15 days since his administration.  He reports that the vaccine was given very high on his arm.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: cellulitis
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted from seated position. no injury. patient has recovered completely and currently experiencing no symptoms.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site discharge, Injection site haemorrhage, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: BD Safety glide needles 25 g x 1 inch faulty - caused blood and vaccine to immediately shoot out of patient arm when removing needle after vaccine. Pt states this happened to her once before when doing a blood draw/lab. LOT 2007149 exp 12-31-26 FAULTY
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Needle issue
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: BD Safety glide needles 25 g x 1 inch faulty - caused blood and vaccine to immediately shoot out of patient arm when removing needle after vaccine. Pt states this happened to her once before when doing a blood draw/lab. LOT 2007149 exp 12-31-26 FAULTY
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: has not resolved.  being refered to allergist
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: Patient does not have any range of motion problem just concerned about the bruising & swelling which is getting better still but there
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: patient came in with severe bruising. this is 5 days after she got the vaccine. the circle around the injection site is at least 3 inches in diameter.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ankylosing spondylitis, Biopsy kidney, Blood test abnormal, Chronic kidney disease, Glomerulosclerosis
Clinical narrative: Diagnosed with stage 4 chronic kidney disease in May 2022.  No prior history of kidney disease.  Diagnosed with ankolosing spondylitis in September 2022, no prior history of autoimmune arthritis
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nephritis, Renal tubular atrophy, Ultrasound kidney abnormal
Clinical narrative: Diagnosed with stage 4 chronic kidney disease in May 2022.  No prior history of kidney disease.  Diagnosed with ankolosing spondylitis in September 2022, no prior history of autoimmune arthritis
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: Generalized Headache that is worse when bending over for 9 days and counting
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Keratitis, Laboratory test normal, Muscular weakness, Myalgia
Clinical narrative: Moderate to severe joint and widespread muscle pain and weakness beginning day after vaccine and still occurring as of 11/12/2022. Keratitis diagnosed on 11/11/2022.No problems prior to vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Mood altered, Pain, Pyrexia
Clinical narrative: Shortness of breath, extreme fatigue, total body soreness, fever, bad mood.
Age: 66.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Arthralgia, Bone cyst, Bursa injury, Cartilage injury, Exostosis
Clinical narrative: ON 08/04/2022 I RECEIVED PCV20 PNEUMOCOCCAL CONJUGATE VACCINE PVC20 ON MY RIGHT SHOULDER AND THE DOCTOR ASSISANT INJECTED IT INTO MY TENDON. 08/08/2022 WENT TO EMERGENCY ROOM FOR SEVERE PAIN. 08/15/2022 WENT TO ORTHOPEDICS AND WAS ORDERED A MRI. 09/06/2022 MRI WAS GIVEN. 09/23/2022 TO SEE MD WAS RECOMMENDED TO SEE A ORTHOPEDIC SURGEON. HAVE A APOINTMENT ON 01/31 2023 9:30 AM  TO SEE DR. TO DISUSSED SURGERY.
Age: 66.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Joint effusion, Ligament disorder, Magnetic resonance imaging, Muscle strain, Oedema
Clinical narrative: ON 08/04/2022 I RECEIVED PCV20 PNEUMOCOCCAL CONJUGATE VACCINE PVC20 ON MY RIGHT SHOULDER AND THE DOCTOR ASSISANT INJECTED IT INTO MY TENDON. 08/08/2022 WENT TO EMERGENCY ROOM FOR SEVERE PAIN. 08/15/2022 WENT TO ORTHOPEDICS AND WAS ORDERED A MRI. 09/06/2022 MRI WAS GIVEN. 09/23/2022 TO SEE MD WAS RECOMMENDED TO SEE A ORTHOPEDIC SURGEON. HAVE A APOINTMENT ON 01/31 2023 9:30 AM  TO SEE DR. TO DISUSSED SURGERY.
Age: 66.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Osteoarthritis, Pain, Rotator cuff syndrome, Tendon disorder, Tendonitis
Clinical narrative: ON 08/04/2022 I RECEIVED PCV20 PNEUMOCOCCAL CONJUGATE VACCINE PVC20 ON MY RIGHT SHOULDER AND THE DOCTOR ASSISANT INJECTED IT INTO MY TENDON. 08/08/2022 WENT TO EMERGENCY ROOM FOR SEVERE PAIN. 08/15/2022 WENT TO ORTHOPEDICS AND WAS ORDERED A MRI. 09/06/2022 MRI WAS GIVEN. 09/23/2022 TO SEE MD WAS RECOMMENDED TO SEE A ORTHOPEDIC SURGEON. HAVE A APOINTMENT ON 01/31 2023 9:30 AM  TO SEE DR. TO DISUSSED SURGERY.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Condition aggravated, Dysmenorrhoea, Full blood count, Heavy menstrual bleeding
Clinical narrative: Change in menstruation following does one and two of vaccine, has not improved since onset, very heavy menstruation, increased duration of menstruation and painful menstruation since the two days following does one of the vaccine, worsened following does two.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Change in menstruation following does one and two of vaccine, has not improved since onset, very heavy menstruation, increased duration of menstruation and painful menstruation since the two days following does one of the vaccine, worsened following does two.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia
Clinical narrative: After 10 hours, extremely intense body aches, soreness, everywhere for 8+ hours.  Fever 102 last night. Now 101.  Physical pain slowly subsiding.  This was worse than when I actually had covid in July 2022.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Electromyogram, Haemorrhagic stroke, Ischaemic stroke
Clinical narrative: Ischemic and Hemorrhagic Stroke (April 30,21),  Stroke (May 4, 2021) Stroke (February 25, 2022)