chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, HEPA, MMRV
Symptoms: No adverse event
Clinical narrative: NO SYMPTOMS
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reactions stated.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: COVID-19 vaccine formulated for individuals 12 years and older was administered to pt. No adverse reaction s/s.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received a full adult dose of Cominarty (Pfizer) Covid-19 Vaccine 0.3mL., which is indicated for Children and adult 12 year and older. Patient is 5 years old.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received Fluad vaccine that was meant for another patient with the same name. Patient had already received flu vaccine in August, so patient received two doses of this year's flu vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: COVID-19 vaccine formulated for individuals 12 years and older was administered to pt. No adverse reaction s/s.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Redness, irritation, swelling at injection site. Was treated for cellulitis by physician with antibiotics.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness and swelling. Very sore
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site reaction, Musculoskeletal stiffness, Rash, Rash erythematous
Clinical narrative: Patient stated she had a stiff neck and a raised red rash on her arm at injection site and moved down her arm  which made 2 differ raised areas and her arm is still bruised 2 weeks later (today 10/9/24)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Patient stated she had a stiff neck and a raised red rash on her arm at injection site and moved down her arm  which made 2 differ raised areas and her arm is still bruised 2 weeks later (today 10/9/24)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "best by" date. Patient notified. No reaction stated
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Computerised tomogram abdomen abnormal, Diarrhoea, Electrocardiogram normal, Leukocytosis
Clinical narrative: abdominal pain, syncope, diarrhea
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Ovarian cyst, Syncope
Clinical narrative: abdominal pain, syncope, diarrhea
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Adult dose was given to under 12. No adverse effects noted.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dyskinesia, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: The muscles in my left hand began to twitch and later convulse rapidly. I could not control it or make it stop. It caused my fingers to flex without my consent. After hours I pinned my hand under my pillow to ignore the sensation and finally fell asleep. By morning it has stopped. My hand has been slightly stiff since.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered adult dose of covid vaccine.
Age: 85.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blood urea abnormal, Creatinine renal clearance abnormal, Diarrhoea, Full blood count normal, Laboratory test abnormal
Clinical narrative: On Sept 19th, patient vomited all of breakfast, then on/off all day with any attempt to eat.  No chills of fever.  Maculopapular rash on buttock without pus, not particulary itchy, about 6-8 spots.  Took ondansetron in evening 4mg )DT x2 ;  Sept 20th , marked decrease in urination; taking only sips of H2O; rash had spread to arms, legs, gront abdomen with redness around papules spreading.  Added Chlorotrimeton 4 mg when rash became very itchy.    Saw PA at PCP office; no diagnosis.  tongue moist, no oral lesions; no increased lymph glands.  Tylenol/Ctm continued.  Ondansetron discontinued due to diarrhea Sept 20th;  Rash continued to spread through Sept 21, then symptoms started to ease.  Sept 22, slept all night and able to eat eggs/toast at breaksfast, then small supper.  Rash improved slowly becoming non-itchy by Sept 25th;  Took a week to clear;  Not full energy Sept 27-Oct 2.  Resolved now
Age: 85.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Metabolic function test normal, Rash, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: On Sept 19th, patient vomited all of breakfast, then on/off all day with any attempt to eat.  No chills of fever.  Maculopapular rash on buttock without pus, not particulary itchy, about 6-8 spots.  Took ondansetron in evening 4mg )DT x2 ;  Sept 20th , marked decrease in urination; taking only sips of H2O; rash had spread to arms, legs, gront abdomen with redness around papules spreading.  Added Chlorotrimeton 4 mg when rash became very itchy.    Saw PA at PCP office; no diagnosis.  tongue moist, no oral lesions; no increased lymph glands.  Tylenol/Ctm continued.  Ondansetron discontinued due to diarrhea Sept 20th;  Rash continued to spread through Sept 21, then symptoms started to ease.  Sept 22, slept all night and able to eat eggs/toast at breaksfast, then small supper.  Rash improved slowly becoming non-itchy by Sept 25th;  Took a week to clear;  Not full energy Sept 27-Oct 2.  Resolved now
Age: 85.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Vomiting
Clinical narrative: On Sept 19th, patient vomited all of breakfast, then on/off all day with any attempt to eat.  No chills of fever.  Maculopapular rash on buttock without pus, not particulary itchy, about 6-8 spots.  Took ondansetron in evening 4mg )DT x2 ;  Sept 20th , marked decrease in urination; taking only sips of H2O; rash had spread to arms, legs, gront abdomen with redness around papules spreading.  Added Chlorotrimeton 4 mg when rash became very itchy.    Saw PA at PCP office; no diagnosis.  tongue moist, no oral lesions; no increased lymph glands.  Tylenol/Ctm continued.  Ondansetron discontinued due to diarrhea Sept 20th;  Rash continued to spread through Sept 21, then symptoms started to ease.  Sept 22, slept all night and able to eat eggs/toast at breaksfast, then small supper.  Rash improved slowly becoming non-itchy by Sept 25th;  Took a week to clear;  Not full energy Sept 27-Oct 2.  Resolved now
Age: 89.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash on dorsal of trunk
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria 24 hrs after receiving vaccine
Age: 51.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: She stated that later that night she had a high fever, swelling at the site. It was also painful and hot. She took APAP and IBU but that did not help. Fever stated at 103F. Also had joint pain. She felt better in the am but had a slight flare. According to pamphlet this is a rare side effect of Shingrix. I advised she not get any more unless MD said otherwise.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive for covid on 06Oct2024; She tested positive for covid on 06Oct2024; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 at 13:20 as dose 1, single (Lot number: EN6206), in left deltoid and on 08Apr2021 at 11:06 as dose 2, single (Lot number: EW0150) at the age of 37 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "she has a lung predisposition" (unspecified if ongoing), notes: had two spontaneous pneumothoraxes and corrective surgery for those when she was age 16; "had two spontaneous pneumothoraxes and corrective surgery" (unspecified if ongoing), notes: when she was age 16; "had two spontaneous pneumothoraxes and corrective surgery" (not ongoing), notes: when she was age 16; "she was diagnosed with fibromyalgia since age 8" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Oct2024, outcome "unknown" and all described as "She tested positive for covid on 06Oct2024". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 102 plus, notes: 10 days of fever; SARS-CoV-2 test: (06Oct2024) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400271861 Same patient and product, Different dose and events;US-PFIZER INC-2021424149 Same patient and product, Different dose and events;
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received two doses of the fluzone hd in the same day with no reported ae; Initial information received on 26-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 69 years old male patient received two doses of the Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] in the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), Concomitant medications and family history were not provided.   On an unknown date, the patient received a 2 dosage form(DF) of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine  (Suspension for injection in pre-filled syringe) (lot UT8437DA,Expiry date: 01-Jun-2025, strength was unknown) via unknown route in unknown administration site for Immunization and patient received two doses of the fluzone hd in the same day with no reported adverse event (extra dose administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; Nurse calling to report the inadvertent administration of an expired dose of PEDVAXHIB to a patient.; This spontaneous report has been received from a nurse, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 03-OCT-2024, the patient was inadvertently vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, as prophylaxis, (lot number U014485 which has been verified to be valid, expiration date reported and established as 26-OCT-2023) (dose, route of administration, anatomical site of injection, and vaccination scheme frequency, were not reported) (Expired product administered).   No additional adverse events were reported in the patient.
Sex: U
Vaccine: COVID19
Symptoms: Transient global amnesia
Clinical narrative: TGA; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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 immunisation. The following information was reported: TRANSIENT GLOBAL AMNESIA (hospitalization), 72 hrs after the suspect product(s) administration, outcome "unknown", described as "TGA". The patient was hospitalized for observation and was not convinced it was not somehow related to receiving the booster.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Myalgia, Vomiting
Clinical narrative: Extreme chills; 3 hours of vomiting; headache; muscle aches; joint aches; Initial information received on 02-Oct-2024 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 69 years old male patient who had extreme chills, 3 hours of vomiting, headache, muscle aches and joint aches after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) ,Concomitant medications and family history were not provided.   On 01-Oct-2024, the patient received a dose 1 of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) (lot number, strength, expiry date not reported) via unknown route in unknown administration site for Flu prevention (Antiviral prophylaxis). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On 01-OCT-2024 the patient developed extreme chills, 3 hours of vomiting , headache , muscle aches (myalgia) and joint aches (arthralgia) (latency : same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Reportedly "Never had a reaction to any other flu or high dose flu shot ."  Action taken was not applicable for all the events.  It was not reported if the patient received a corrective treatment for the events (Extreme chills, muscle aches, headache, 3 hours of vomiting, joint aches).  At time of reporting, the outcome was Recovering / Resolving for all the events.  Seriousness Criteria : All the events were assessed as disability.; Sender's Comments: Sanofi Company Comment dated 09-Oct-2024 : This case involves a 69-year-old male patient who had extreme chills, 3 hours of vomiting, headache, muscle aches and joint aches after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance,laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: she got vaccines while pregnant, with no reported adverse event; Initial information received on 25-Sep-2024 regarding an unsolicited valid social media non-serious case received from a patient.  This case involves an unknown age female patient who was exposed to vaccine Influenza Vaccine in context of she got vaccines while pregnant, with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported she got vaccines while pregnant and with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the pregnant patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer, with no reported adverse event (maternal exposure during pregnancy) (latency: same day) (form, strength: not reported) (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Hypersensitivity
Clinical narrative: systemic reactions of an allergic reaction; felt weak; dizzy; Initial information received on 20-Sep-2024 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to other cases 2024SA285980, 2024SA285853, 2024SA286193 and 2024SA286870.  This case involves a 20-year-old female patient who had systemic reactions of an allergic reaction, felt weak and dizzy while receiving vaccine rabies (HDC) vaccine [Imovax rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphenhydramine hydrochloride (Benadryl).  On 09-Sep-2024, the patient received a standard dose 1 of 0.1 ml suspect rabies (HDC) vaccine Powder and solvent for suspension for injection with lot W1C931M and expiry date 31-Oct-2025 via intramuscular route in the left arm for immunization. On 16-Sep-2024 she also received a dose 2 of 0.1 ml of vaccine with lot W1C931M and expiry date 31-Oct-2025 via intramuscular route in the left arm for immunization.  In SEP-2024 the patient developed systemic reactions of an allergic reaction (hypersensitivity), felt weak (asthenia), dizzy (dizziness) (unknown latency) following the administration of rabies (HDC) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.; Sender's Comments:  2024SA285980:02230589 2024SA285853:0220987 2024SA286193:02230981 US-SA-2024SA286870:02232595
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: during the course of initial vaccine the full volume/dose was not received by the patient with no reported adverse event; Initial information received on 21-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient that during the course of initial vaccine the full volume/dose of influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] was not received by the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (unknown strength, lot and expiry date) via unknown route in unknown administration site for vaccination (immunization).  On an unknown date the course of initial vaccine the full volume/dose of unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (unknown strength, lot and expiry date) via unknown route in unknown administration site for vaccination (immunization) was not received by the patient with no reported adverse event (incorrect dose administered) (latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence   Reportedly, the reporter stated that Fluzone HD immunization should be repeated if during the course of initial vaccine the full volume/dose was not received by the patient   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: FLU3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: had two doses of FLUZONE NP 0.5 ml but it was less than four weeks apart with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse with a live follow-up processed together (CSD: 25-Sep-2024).  This case involves a 12 months old female patient who had two doses of influenza USP trival A-B subvirion no preservative vaccine [FLUZONE] 0.5 ml but it was less than four weeks apart 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 COVID-19 vaccine for Immunisation.  On an unknown date in 2024, the patient received an unknown dose 1 of influenza USP trival A-B subvirion no preservative vaccine Suspension for injection (strength, lot number and expiry date not reported) via unknown route in unknown administration site and on 24-Sep-2024 she also received 0.5 ml of dose 2 of same vaccine with standard strength (lot number- UT8434MA and expiry date- 30-Jun-2025) once via intramuscular route in the left vastus lateralis for Immunization which was less than four weeks apart with no reported adverse event (inappropriate schedule of product administration) (latency- same day).  Information on the batch number and expiry date was requested corresponding to the one at time of event occurrence for dose 1.   Reportedly, no treatment as received.   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: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: stated that one of their medical assistants administered ADACEL subcutaneously, instead of intramuscularly with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from another healthcare professional.  This case involves a 25-year-old female patient, and the reporter stated that one of their medical assistants administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] subcutaneously, instead of intramuscularly with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 20-Sep-2024, the patient received a standard dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection with dose 0.5 ml once (unknown lot number and expiry date) via intramuscular route in the back of the arm for immunization and reporter stated that one of their medical assistants administered adacel subcutaneously, instead of intramuscularly with no reported adverse event (incorrect route of product administration) (latency same day).   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: 34.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: adacel was given post excursion with no reported adverse event; Initial information received on 25-Sep-2024 regarding an unsolicited valid non-serious case received from an Nurse.  This case involves a 34 years old male patient where diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] was given post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2024, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (Strength- standard) (lot- U8231AA and expiration date- 31-MAY-2026) via intramuscular route in the right deltoid for immunization and adacel was given post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Product/s: (Opened or Unopened) (unopened) MENQUADFI and ADACEL Reason: Cause of excursion is unknown happened in the middle of the night max/low temperature reached: -1.3 degrees c duration: 20 minutes Previous Excursion? no Human error? no Administered post-excursion? adacel was given post excursion Does extended stability data cover the excursion? No.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 0.17
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of ipol temperature reached: 9.3°C duration: 30 minutes with no reported adverse event; ipol administered after excursion with no reported adverse event; Initial information received on 25-Sep-2024 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves a 9 weeks old female patient and reporter reported that temperature excursion of ipol temperature reached: 9.3°c duration: 30 minutes with no reported adverse event and ipol administered after excursion 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix).  On 23-Sep-2024, the patient received standard dose of 0.5 ml dose of suspect IPV (VERO) suspension for injection once with lot W1C741M and expiry date 17-Nov-2025 via intramuscular route in the left thigh for imunization.  On an unknown date Ipol exposed to temperature excursion and temperature reached: 9.3°c duration: 30 minutes with no reported adverse event (product storage error) (unknown latency)   On 23-SEP-2024 the patient administered ipol after excursion with no reported adverse event (poor quality product administered) (Latency same day).  Reportedly, product was administered and there was no previous excursion.   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: 2.0
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Off label use, Wrong product administered
Clinical narrative: QUADRACEL, was inadvertently administered to an underage patient.  The patient was supposed to receive Pentacel with no reported adverse event; QUADRACEL, was inadvertently administered to an underage patient.  The patient was supposed to receive Pentacel with no reported adverse event; Initial information received on 25-Sep-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 2-year-old male patient and the reporter reported that diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine (Quadracel) was inadvertently administered to an underage patient. the patient was supposed to receive diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (Pentacel).  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine CONJ 7V (CRM197) (Prevnar).  On an unknown date, the patient received standard dose 0.5 ml of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine solution for injection once with lot U7931AB and expiry date 09-Nov-2025 via intramuscular route in the left thigh for immuization was inadvertently administered to an underage patient. the patient was supposed to receive Pentacel (wrong product administered) (off label use) (latency same day) for both.  Reportedly, the reporter stated that This situation is pre-assessed as an off label use as per local labelling due to the use of the product to a person under the required age on the label. Medical assistant reporting that quadracel, was inadvertently administered to an underage patient.  The patient was supposed to receive Pentacel   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: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidently administered the FLUZONE HD QUAD that was expired, with no reported adverse event; Initial information received on 26-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 80 years old male patient who was accidently administered the influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] that was expired, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2024, the patient was accidently administered a 0.7 ml dose of suspect Influenza Quadrival A-B High Dose HV Vaccine of lot UT8057CA and expiry date: 30-Jun-2024 (strength: standard and frequency: once) via intramuscular route in the left arm for immunization that was expired, with no reported adverse event (expired product administered) (latency: on same day).  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: 53.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site warmth, Pain, Pain in extremity, Tenderness
Clinical narrative: incredibly sore arm, even at the slightest touch, also movement , pressure are painful.  In addition, now there is a pink, hot area at injection site approximately 2? wide and 1? in length.  Oval, oblong shape.  Feels quite warm/hot,  significantly more so than rest of arm which feels quite cool.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Mobility decreased, Muscle disorder, Muscular weakness
Clinical narrative: Guillain-Barre (severe muscle weakness, loss of muscular function - mobility). No improvement over past 12 days
Age: 41.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Headache, Pain in extremity, Rhinorrhoea
Clinical narrative: Headaches around the clock for 3 days, arm pain from injections. Runny nose also. Took otc meds  for pain relief, no fever
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Decreased appetite, Ear pain, Eye swelling, Facial paresis
Clinical narrative: Bell's Palsy                                                                                                                                                                                                                                  - Presents with left-sided facial weakness and inability to smile or blink left eye following COVID booster vaccination on 10/30/2024  - Developed fatigue and mild symptoms the day after vaccination, followed by muscle spasms in left lower lip 2 days post-vaccination ("I felt really tired, and then the next day, I felt, like, just very mild symptoms", "And then I started having, like, my lips should have, like, have a muscle spasms") - Left eye swelling and worsening facial weakness noticed 3 days post-vaccination on 11/02/2024 ("Friday, I woke up, and my eye felt swollen") - Difficulty eating and inability to smile or fully close left eye ("It's hard to eat. I can't smile at all. And I can't blink my eye") - Severe left ear and throat pain on night of 11/01/2024, interfering with sleep  - Left-sided tongue weakness, now resolved - Denies hearing loss - Denies breathing difficulties.                             No treatment recommended due to history of steroid intolerance and duration of symptoms.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Oropharyngeal pain, Sleep disorder, Tongue movement disturbance
Clinical narrative: Bell's Palsy                                                                                                                                                                                                                                  - Presents with left-sided facial weakness and inability to smile or blink left eye following COVID booster vaccination on 10/30/2024  - Developed fatigue and mild symptoms the day after vaccination, followed by muscle spasms in left lower lip 2 days post-vaccination ("I felt really tired, and then the next day, I felt, like, just very mild symptoms", "And then I started having, like, my lips should have, like, have a muscle spasms") - Left eye swelling and worsening facial weakness noticed 3 days post-vaccination on 11/02/2024 ("Friday, I woke up, and my eye felt swollen") - Difficulty eating and inability to smile or fully close left eye ("It's hard to eat. I can't smile at all. And I can't blink my eye") - Severe left ear and throat pain on night of 11/01/2024, interfering with sleep  - Left-sided tongue weakness, now resolved - Denies hearing loss - Denies breathing difficulties.                             No treatment recommended due to history of steroid intolerance and duration of symptoms.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, RV5, UNK
Symptoms: Abdominal pain, Dehydration, Diarrhoea, Haematochezia, Intussusception
Clinical narrative: Patient presented with vomiting and diarrhea on 10/8, had lethargy and decreased urine output on 10/9- unable to keep formula down. Presented to ED for symptoms and admitted for dehydration and decreased urine output. After admission, noted to have colicky abdominal pain and bloody stools. Ultrasound demonstrated intussusception in LLQ. She was transferred to Hospital for treatment (no pediatric surgery available at this facility).
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, RV5, UNK
Symptoms: Lethargy, Ultrasound abdomen abnormal, Urine output decreased, Vomiting
Clinical narrative: Patient presented with vomiting and diarrhea on 10/8, had lethargy and decreased urine output on 10/9- unable to keep formula down. Presented to ED for symptoms and admitted for dehydration and decreased urine output. After admission, noted to have colicky abdominal pain and bloody stools. Ultrasound demonstrated intussusception in LLQ. She was transferred to Hospital for treatment (no pediatric surgery available at this facility).
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Limb discomfort, Tremor
Clinical narrative: experienced intense chills; could not even hold a glass of water due to the shaking; little discomfort in his arm; Initial information received on 20-Sep-2024 regarding an unsolicited valid  non-serious case received from a patient.  This case involves a 77 year old male patient who had experienced intense chills, could not even hold a glass of water due to the shaking and little discomfort in his arm after receiving influenza USP trival A-B high dose subvirion vaccine [fluzone HD].  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (unknown strength) with lot U8489DA and expiry date 30-Jun-2025 via unknown route in unknown administration site for Influenza (influenza immunization).  On an unknown date the patient experienced intense chills (chills), could not even hold a glass of water due to the shaking (tremor), little discomfort in his arm (limb discomfort)  (latency same day) following the administration of influenza USP trival A-B high dose subvirion vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 86.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: pt had nausea, vomiting and fatigue for about 10 days following vaccination
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Death, Fall, Gait disturbance
Clinical narrative: Pt received vaccine @ 615/PM. Pt got OOB at 1101/PM fell to floor with death resulting. Pt could not ambulate independently. Fall was unwitnessed.
Age: 1.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Urticaria
Clinical narrative: Had 6 m well child check and receivced vaxelis, PCV20 + nirsevimab. The following day mom noticed several hives (9 tota) on her extremitites
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Electrocardiogram normal, Immediate post-injection reaction, Pharyngeal swelling, Pulmonary embolism
Clinical narrative: Patient called health department to report symptoms around 1:10 pm 10/8/24, stated "right after I received my flu shot, my throat started sticking and felt scratchy, like I had something in it, I thought it was swelling up like I had a reaction." Was told see MD of go to E.R. or urgent care. Seen by PCP at 2:00pm
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Patient called health department to report symptoms around 1:10 pm 10/8/24, stated "right after I received my flu shot, my throat started sticking and felt scratchy, like I had something in it, I thought it was swelling up like I had a reaction." Was told see MD of go to E.R. or urgent care. Seen by PCP at 2:00pm
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Nausea
Clinical narrative: About 4pm I developed chills and went to bed soon after. During the night my temperature reached 102.5 and I felt like vomiting. I took two Tylenol and this morning my temperature was normal.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Retching, Throat tightness, Visual impairment
Clinical narrative: Within approx. 2 min. patient felt a tightness in throat and SOB.  Wrists and ankles were blood shot red. Saw stars and started dry heaving.
Age: 1.83
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling abnormal, Inflammation
Clinical narrative: Mild redness, woody feeling,  inflamed area right thigh 3 cm circular
Age: 0.67
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Injection site mass
Clinical narrative: Patient has 2 lumps on left thigh where vaccines were given about 4 weeks ago. They are not red or tender, patient is using both legs normally.  It was the patient's first dose of Vaxelis, but third time getting all the vaccines in Vaxelis (she got pentacel and energix for previous doses).
Age: 16.0
Sex: F
Vaccine: COVID19, FLU3, HPV9, MNQ
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: Left arm with erythema, induration of 3 inches, pain
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Patient received vaccination with no initial adverse effects.  She returned to pharmacy after less than 10 minutes reporting unexplained shortness of breath and tightness in chest.  RPh guided her to seated position to triage situation.  Patient was instructed to breathe slowly and deeply and try to relax; an EpiPen was not required.  She was given oral fluid hydration and made a recovery within 15 minutes.  RPh tried several times to reach out to patient over the course of the week, but patient did not return calls.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Induration, Pain
Clinical narrative: Erythema, Induration of 3 inches approximately and pain
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest pain, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: During the day I had typical side effects from COVID vaccine that I have experienced with previous COVID vaccines and boosters: muscle aches and pains and mild fever (101 deg F)  starting around 10:00am on 10/5/2024. That night I was awoken by right side chest pain around 2am. The chest pain was constant and felt like a "spiky" nerve pain through the right upper 2/3 of my torso. It did not feel like pressure. It lasted around two hours. I would give the pain level a 5/10.  After about 2 hours it subsided and I was able to go back to sleep. I did not seek medical attention as I noted this is a rare side effect from the COVID vaccine that appeared to resolve with time. COVID vax history: (1) 04/03/2021 Pfizer; (2) 04/25/2021 Pfizer; (3) 10/25/2021 Pfizer; (4) 10/5/2022 Moderna; (5) 11/10/2023 Moderna; (6) 10/4/2024 Pfizer. I also got a flu shot the same date/time on 10/04/2024. I have been getting these vaccines together the last few years without incident. Looking at the history, I believe this may be the first time getting the Pfizer COVID vaccine and the flu shot together.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received vaccine on 10/7/24 around 4.30pm. Mom called clinic on 10/9/24 around 11 am and said school nurse called and patient had red knot on her arm in area of vaccine that was size of 2 golf balls. Mom was on the way to pick up child and she denied any difficulty breathing or rash. Advised to give a dose of benadryl and hold ice pack on the site for several minutes at a time until patient can be seen in clinic at 1.40 pm.  Patient was evaluated by Dr on 10-9-24 and she had swelling and redness at the site with 3CM of calor.  Advised to continue zyrtec as needed for itching and gave 3 day course of prednisone to help with inflammatory response.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Hypotonia, Lethargy, Vomiting
Clinical narrative: Patient had left office for about 20 min, started vomiting profusely , called office, directed to ER.   From the ER, they were directed to urgent care.   He was limp lethargic and had vomiting, no airway swelling, no hives.   At urgent care, vitals taken assessed and within a few minutes he was acting normal with no epinephrine given.  He was treated with zofran and observed.   Patient evaluated in pediatrician office next day and was at normal baseline health.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 48 y/o female given Fluzone High Dose Vaccine rather than Flublok.  No known adverse event or reaction reported.   Caught on chart audit
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe hives all over body.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pediatric dose given instead of adult dose
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Muscular weakness, Plasmapheresis
Clinical narrative: Patient developed Guillain Barre Syndrome, presented  2 weeks after MenQuadfi vaccine with severe lower extremity weakness and required intubation for respiratory support and required plasma exchange 5 times.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Erythema, Pruritus, Urticaria
Clinical narrative: Itching, redness, hives, crampy abdominal pain, loose bowel movement, vomiting. Treated with Benadryl. Resolved.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Itching, redness, hives, crampy abdominal pain, loose bowel movement, vomiting. Treated with Benadryl. Resolved.
Age: 44.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Chills and pounding headache after approximately 3 hours. Nausea and fatigue upon waking at 6:30 am the next day. Left arm injection site tenderness and aching starting mild and progressing to moderate upon waking.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: For the second year I developed sporadic hives mainly on my upper legs, behind my knees, and two on my left torso. One on my left hand could be a bug bite, but I don?t know. I was itching a lot the evening 4 days after the vaccine and overnight I developed the hives. I took Allegra for the itching but it did nothing. I was prescribed a Medrol pack Friday 10/4 which helped plus topical betamethasone. There are a dozen or so hives and the itching has been awful. I remember the same thing happening last year after my Moderna COVID booster after a week. I think this year started sooner and was much more itchy.
Age: 3.0
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: Vaxelis was administered which made Dtap component  the forth dose in the series
Age: 1.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a combination vaccine of Dtap and Polio.Patient should have been given these 2 vaccines separately. This dose still counts as a valid dose and does not have to be repeated.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient did not show on system that she had received the RSV vaccine, but patient had two names in the database system and charts were not merged. Patient received a second dose of the RSV vaccine,