chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis exacerbated after receiving a vaccine, Skin went very scaly.; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774658 (Moderna).  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 included: "psoriasis" (ongoing), notes: psoriasis since was 22 years old. The patient's concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious), outcome "recovering", described as "Psoriasis exacerbated after receiving a vaccine, Skin went very scaly.   Additional information: Reporter asked about Spikevax (COVID-19 Vaccine, mRNA) (2024-2025 Formula) and reporter stated that psoriasis exacerbated after receiving a vaccine from Pfizer. The reporter stated that had a big reaction to it stating my skin went very scaly. The call reporter stated that the clinic, where got the vaccine, was caught off-guard with reaction. The reporter stated that Clinic stated that Moderna is a better product for .The reporter further elaborated that had the psoriasis since was 22 years old, and is now years old. The reporter also stated that psoriasis was currently under control.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: TDAP
Symptoms: Type 1 diabetes mellitus
Clinical narrative: developed type one after a vaccine; Initial information received on 22-Sep-2024 regarding an unsolicited valid Social Media serious case received from a consumer/patient.  This case involves Adult female patient who developed type one after Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection in pre-filled syringe via unknown route in unknown administration site for prophylactic vaccination (Immunisation) (strength, dose, batch number and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested  On an unknown date the patient developed type one after a vaccine (type 1 diabetes mellitus) (unknown latency).  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   Seriousness criteria-medically significant for event; Sender's Comments: Sanofi Company Comment dated 07-Oct-2024: This case involves Adult female patient who developed type one after Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations can not be denied for alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Sex: U
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: Injection site soreness; Initial information received on 23-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had injection site soreness after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok QIV].  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  unknown dose of suspect Influenza Quadrivalent Recombinant Vaccine (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient developed injection site soreness (vaccination site pain) (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine.  Reportedly "This past week I received the Flublok Vaccine for myself and overall, it has been a good experience.  I was expecting a stronger reaction to it, but it was the opposite.  This vaccine was easier to take than previous flu vaccines I have taken in my life. "  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Injection site soreness).  At time of reporting, the outcome was Unknown for the event injection site soreness.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 25-year-old patient was inadvertently administered fluzone hd with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 25 years old female patient who was inadvertently administered Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2024, the 25 years old female patient received (0.5 ml) dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (strength: not reported), with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (lot: U8507CA, Expiry date: 30-Jun-205) via intramuscular route in unknown administration site for immunization.  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: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administered a tetanus shot twice to the same patient this month with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 years old male patient who got administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] shot twice to the same patient this month 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 Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for Immunisation.  On 05-Sep-2024, the patient received 0.5 ml dose 1 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot- 3CA22C1 and expiration date- 28-FEB-2026) via unknown route in the left deltoid. On 23-Sep-2024 he also received 0.5 ml dose 2 of vaccine via unknown route in the left deltoid (strength: not provided) from Immunisation and administered a tetanus shot twice to the same patient this month with no reported adverse event (inappropriate schedule 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.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: open ipol exposed to going above refrigeration and reaching 47.1 degrees F for 0.5 hours due to taking inventory with no reported adverse event; vaccine was administered post -excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IMOVAX POLIO] exposed to going above refrigeration and reaching 47.1 degrees f for 0.5 hours due to taking inventory with no reported adverse event and vaccine was administered 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 an unknown date, the patient received a unknown dose of suspect IPV (VERO) (Suspension for injection) (lot W1B511M, Expiry date: 08-Sep-2025, strength was unknown)  via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and open ipol exposed to going above refrigeration and reaching 47.1 degrees f for 0.5 hours due to taking inventory with no reported adverse event (product storage error) (unknown latency) and vaccine was administered post -excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly "The Nurse reported that they are having an audit and it was shown the IPOL encountered a temperature excursion; that based on their documentation the excursion occurred during a time the fridge door was open during routine inventory; that the fridge was not left open outside of normal parameters; that also at that time 2- vaccinations occurred; that since the excursion possibly 12-patients may have had the vaccine but it is not sure yet due to still doing the audit. hours Previous Excursion? No. Human error? yes. Administered post-excursion? yes. Does extended stability data cover the excursion? yes."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Neurological symptom
Clinical narrative: stroke like symptoms; left side of her body went numb on the side where she received the vaccine; dizziness; Initial information received on 24-Sep-2024 regarding an unsolicited valid serious case received from a consumer/non-heathcare professional.  This case involves a 69-year-old female patient who experienced stroke like symptoms, left side of her body went numb on the side where she received the vaccine and dizziness after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe of lot UT8437BA (strength, expiry date: not reported) via unknown route in unknown administration site as Influenza (Influenza immunization).  On an unknown date the patient's left side of her body went numb on the side where she received the vaccine (hypoaesthesia) and dizziness (latency: 2 hours) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine.   On 23-SEP-2024 the patient developed stroke like symptoms (cerebrovascular accident), (unknown latency) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine.   Seriousness criteria: The event Cerebrovascular accident was assessed as medically significant and was hospitalized for the same. She will be receiving an MRI (magnetic resonance imaging) today.  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 the events.; Sender's Comments: Sanofi company comment dated 08-Oct-2024: This case involves a 69-year-old female patient who experienced stroke like symptoms, left side of her body went numb on the side where she received the vaccine and dizziness after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD].The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: No adverse event
Clinical narrative: fluzone np was administered instead of the intended fluzone hd with no reported ae; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This cases is linked to cases- US-SA-2024SA289123, US-SA-2024SA288677, US-SA-2024SA288939  This case involves a 71 years old female patient to whom fluzone np (INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]) was administered instead of the intended INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no reported ae (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 24-Sep-2024, the patient received 0.5 ml x1 (once) of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection lot UT8496KA Expiration Date :30-JUN-2025 via intramuscular route in unknown administration site for Immunization (strength unknown) instead of the intended fluzone hd with no reported ae (wrong product 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.; Sender's Comments:  US-SA-2024SA289123: US-SA-2024SA288677: US-SA-2024SA288939: US-SA-2024SA289123:
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently administered FLUZONE NP instead of the intended FLUZONE HD with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases- US-SA-2024SA288677, US-SA-2024SA288939 and US-SA-2024SA288760  This case involves a 84 years old male patient who was inadvertently administered fluzone np (INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]) instead of the intended  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] 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 (COVID-19 vaccine).  On 24-Sep-2024, the patient inadvertently administered INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection 0.5 ml x1 (once) lot UT8496KA expiry- 30-Jun-2025 via unknown route in unknown administration site for Immunization (strength unknown) instead of the intended fluzone hd with no reported adverse event (wrong product 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.; Sender's Comments:  US-SA-2024SA288677:02236586 US-SA-2024SA288760: US-SA-2024SA288939:
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Wrong product administered
Clinical narrative: fluzone np was administered instead of the intended fluzone hd, with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  The case is linked to US-SA-2024SA288760, US-SA-2024SA289123, US-SA-2024SA288939 and US-SA-2024SA288760.  This case involves a 81 years old female patient who received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] was administered instead of the intended Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] , 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 24-Sep-2024, the patient received a  dose of 0.5 ml of (Frequency : Once) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (Suspension for injection) (lot UT8496KA, Expiry date: 30-Jun-2025,strength was unknown) via intramuscular route in unknown administration site for Immunization instead of the intended fluzone hd, with no reported adverse event (wrong product administered) (latency : same day).  Reportedly "Call received from pharmacist reporting 4 patients were inadvertently administered FLUZONE NP instead of the intended FLUZONE HD. Caller with question on whether dose needs repeating with FLUZONE HD. This situation is pre-assessed as a medication error/an inappropriate use due to FLUZONE NP was administered instead of the intended FLUZONE HD."   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.; Sender's Comments:  US-SA-2024SA288760:02236557 US-SA-2024SA289123:02236586 US-SA-2024SA288939:02236588 US-SA-2024SA288760:02236648
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently administered FLUZONE NP instead of the intended FLUZONE HD with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a physician.  The case is linked to US-SA-2024SA288677, US-SA-2024SA288760, US-SA-2024SA289123 and US-SA-2024SA288939.  This case involves a 79 years old male patient who was inadvertently administered Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] instead of the intended Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] 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 24-Sep-2024, the patient received a  dose of 0.5 ml of (Frequency: Once) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (Suspension for injection) lot UT8496KA, Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in unknown administration site for Immunization and inadvertently administered fluzone np instead of the intended fluzone hd with no reported adverse event (wrong product administered) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to FLUZONE NP was administered instead of the intended FLUZONE HD.Call received from pharmacist reporting 4 patients were inadvertently administered FLUZONE NP instead of the intended FLUZONE HD.  Caller with question on whether dose needs repeating with FLUZONE HD. "   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. ; Sender's Comments:  US-SA-2024SA288677:02236588 US-SA-2024SA288760:02236557 US-SA-2024SA289123:02236586 US-SA-2024SA288760: US-SA-2024SA289123:
Sex: U
Vaccine: UNK
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: A leakage occurred while the HCP was administering the vaccine, so full dose was not given; HCP had a leakage during the administration; Syringe was leaking and some of the liquid leaked onto the patient's arms; This spontaneous case, initially received on 02-Oct-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for influenza immunization, Dosing regimen: not reported, route of administration: not reported, Lot number: No batch number available, would be requested on follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced A leakage occurred while the HCP was administering the vaccine, so full dose was not given (outcome: Unknown), HCP had a leakage during the administration (outcome: Unknown), Syringe was leaking and some of the liquid leaked onto the patient's arms (outcome: Unknown).  Health care professional (HCP) had a leakage happen during administration of Fluad. Patient received a underdose, less than 0.5 ml. A leakage occurred while HCP was administering the vaccine, so full dose was not given. Syringe was leaking and some of the liquid leaked onto the patient's arms. One unit was defective, and the defect was noticed during use, when applying the dose to the patient while withdrawing the needle. The plugger was depressed. No signs of damage were presented in the syringe or needle. A 25G 1 inch needle was used in administration. The needle appeared tightly attached.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the event as non-serious and causality was not reported.; Reporter's Comments: All events were considered not related
Sex: M
Vaccine: FLUX, UNK
Symptoms: Arthropod bite, Pruritus, Urticaria
Clinical narrative: Bug bites are now itchy; Bug bites; Welts on his skin; This spontaneous case, initially received on 01-Oct-2024, was reported by a non health professional and concerns an elderly male patient.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On an unknown date, the patient received Influenza virus vaccine for Influenza Vaccine, dose regimen: not reported; route of administration: not reported; Lot number: No batch number available and would be requested with follow-up.  Non-company suspect drugs: Leqvio (Inclisiran sodium).  Adverse reactions/events and outcomes: On an unknown date, the patient experienced bug bites are now itchy (outcome: Unknown), bug bites (outcome: Unknown), welts on his skin (outcome: Unknown).  Patient reported he just received his flu shot and Covid-19 Vaccine. Patient reported that since starting with Leqvio, he has noticed that if he gets bitten by a bug, the bug bites are more reactive. Patient reported that the bug bites are now itchy and leaving welts on his skin.    Influenza virus vaccine action taken: Not Applicable Leqvio action taken: Not Applicable.  Reporter assessment: The reporter did not provide the seriousness and causality assessment.; Reporter's Comments: Causality: related.
Sex: F
Vaccine: UNK
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Pharmacist was going to administer the vaccine and when pressed down the syringe, the actual vaccine spayed out below the Luer Lok/ the liquid was sprayed out on herself and the patient; when pressed down the syringe, the actual vaccine spayed out below the Luer Lok; This spontaneous case, initially received on 30-Sep-2024, was reported by a health professional and concerns a female patient.  Administration of company suspect drug(s): On 24-Sep-2024, the patient received Flucelvax (TIV) for Indication not reported, dosing regimen: not reported, route of administration: not reported, Lot number: 388518.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 24-Sep-2024, the patient experienced Health professional was going to administer the vaccine and when pressed down the syringe, the actual vaccine spayed out below the Luer Lok/ the liquid was sprayed out on herself and the patient (outcome: Not Reported), when pressed down the syringe, the actual vaccine spayed out below the Luer Lok (outcome: Not Reported). When health professional was going to administer the vaccine and when pressed down the syringe, the actual vaccine spayed out below the Luer Lok. The needle was fine. Health professional put the needle in the patient and then pressed the plunger of the syringe and the liquid was sprayed out on herself and the patient. It was confirmed that this only happened to one unit and the second vaccine was administered to the patient. Unit affected was not available to send back or send pictures since it was dropped in sharp container. It seemed that the little part where the Luer Lok was for the needle may have been a bit crooked.   Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide a seriousness or causality assessment.  07-OCT-2024 (System Update): Linked Case ID(s):2024180959 (Patient Link); Reporter's Comments: Company causality: Not related
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Patient husband came in today tp pick up medication and informed us that his wife, after she got the flu vaccine last 10/6/24 , she experienced hives and a little swelling of her tongue around 4 hours after she had the vaccine. She went to the emergency room  after . He said she felt better after the trip to the emergency room.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine give outside "Best By" date. Patient notified. No reaction stated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine given was pediatric dose not adult dose. No adverse event other than incorrect dose. Repeat pediatric dose given to equal adult dose per CDC and documented as such.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Throat irritation
Clinical narrative: About 10 minutes after the vaccine administration, patient reported feeling scratchiness in her throat and injection site was feeling itchy/red. 25 mg of IM Benadryl administered and patient reported feeling much better a couple minutes later. Throat cleared up and no more itchiness. Patient waited 5 additional minutes and was stable to be released.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. NO reaction stated.
Age: 71.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: patient called stating he has about 8 small bumps on the left arm. They do not hurt, itch he noticed them when showering.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine given was pediatric dose not adult dose. No adverse event other than incorrect dose. Repeat pediatric dose given to equal adult dose per CDC and documented as such.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: PHARMACIST DID NOT REALIZED PATIENT ALREADY GOT 2024-2025 FLUSHOT ON 08/08/24 THUS THIS PATIENT RECEIVED THE FLUSHOT FOR THE SECOND TIME DURING THE SAME SEASON
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine given was pediatric dose not adult dose. No adverse event other than incorrect dose. Repeat pediatric dose given to equal adult dose per CDC and documented as such.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine given was pediatric dose not adult dose. No adverse event other than incorrect dose. Repeat pediatric dose given to equal adult dose per CDC and documented as such.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Palpitations
Clinical narrative: The next day after the vaccine, I felt my heart racing. I wasn't able to reduce my heart rate with breathing exercises or by meditating. My heart rate normalized at the end of the day. I did not seek emergency care, but I did contact my primary care physician, who directed me to this form.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Pain in extremity, Sleep disorder
Clinical narrative: The patient informed pharmacy that he experienced arm soreness and shoulder pain, body weakness and fatigue that same evening at bedtime on 10/5/24 ( about 7 hours after the vaccination) , trouble sleeping. No fever, no headache, no chills. He stated he took Advil PM. He did feel better he stated by 8am the next morning on 10/6/24. Follow up on 10/8/24 by RPH, patient feels better.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Cough, Headache, Lymphadenopathy
Clinical narrative: bad headache, cough, swollen lymph nodes in neck, chest pain
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported to date patient was given two high flu vaccines by accident.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain that has not resolved since injection.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever for 3-4 days, rash
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Rash, Rash erythematous, Rash papular
Clinical narrative: My son felt a soreness in one calf muscle within an hour after the injection. He described the soreness as feeling like a loss of circulation. There was no discoloration of the calf, and the feeling went away within about an hour. Later that night, about 5 h post-injection, I noticed he had a rash on one thigh. It looked like a reddened, slightly raised plaque with some smaller red bumps to the side and below it. It did not itch, and it was gone by morning.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Malaise, Musculoskeletal chest pain, Myalgia, Pyrexia
Clinical narrative: Patient felt terrible, muscle aches, sore knees, chest muscle pain, fever over 101.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: after 1 week of shingrix vaccine, pt developed rashes, blister on the right upper quaddrant abdomen .  It keep spreading. No pain though. patient went to see his primary care doctor and was dignosis with shingle and was given a cream  for it. It takes a long time before the rashes resolve
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: patients came in on 10/8 to notify us that he had a rash on his abdomen and his back after receiving his vaccinations.  he was able to self treat(did nothing to treat and is resolving on its own)
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Loss of personal independence in daily activities, Myalgia
Clinical narrative: None stated.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: None stated.
Age: 18.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Confusional state, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient receiving flu and covid vaccines at 12:49 pm and lost consciousness at 12:50 pm after making it to the observation area and sitting down. She was laid on the ground and quickly regained consciousness. She was pale, sweaty, and confused. She regained color within a few minutes and became less confused. She was taken to the emergency room at 1:20 pm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Nausea
Clinical narrative: Starting about three hours after the 1st shot I was overcome with a kind of most unusual exhaustion and weakness; such that in order to move around the house, I had to hold on to walls and furniture to move from place to place, room to room.  I also felt quite nauseous all day.  These effects lasted almost 12 hours.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine entered in EMR and given to patient. Patient given Proquad vaccine in error . Supposed to be Quadracel
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Pt given regular adult flu vaccine instead of high dose vacccine. Supervisor notified, provider PA-C notified. Per provider, pt should be okay. Advised pt to watch for any shortness of breath, hives, or chest pain. Pt notified and advised that she would be notified of if further action needs to be taken. Pt waited 15 mins with no reaction to vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 1.67
Sex: F
Vaccine: MMR
Symptoms: Cough, Enanthema, Eye discharge, Inappropriate schedule of product administration, Measles
Clinical narrative: although our patient was vaccinated against measles, she did not have IgG circulating antibodies for measles; although our patient was vaccinated against measles, she did not have IgG circulating antibodies for measles; the patient received the first dose after 15 months of age; Literature report.  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 2-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The patient received the first dose after 15 months of age. (Inappropriate age at vaccine administration). The patient was vaccinated against measles 4 months prior to presentation  The patient was admitted to the pediatric inpatient service with a 5-day history of tactile fever, with associated cough, runny nose, and rash. She had a generalized maculopapular rash initially on her face, which then spread to her trunk and extremities. Other positive findings included bilateral clear, watery eye discharge, nasal congestion, and a white enanthem noted on buccal mucosal surfaces. She was noted to be inconsolable and not soothed by her mother during examination. Differential diagnosis included scarlet fever, Kawasaki disease, and viral exanthem; however, due to the recent exposure to confirmed cases of measles, she was placed on airborne isolation precautions. Nasopharyngeal polymerase chain reaction (PCR) for measles was positive, and immunoglobulin G (IgG) measles antibody was negative, confirming an active infection (Vaccination failure, Measles antibody negative).  At the time of reporting, the outcome of Vaccination failure, and Measles antibody negative was unknown. The action taken with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  regarding Vaccination failure, Measles antibody negative was reported as Not Applicable.   The reporter considered Vaccination failure and Measles antibody negative to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  A copy of the published article is attached as further documentation of the patient's experience.  Lot # is being requested and will be submitted if received.
Age: 1.67
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Morbillivirus test positive, Nasal congestion, Pyrexia, Rash
Clinical narrative: although our patient was vaccinated against measles, she did not have IgG circulating antibodies for measles; although our patient was vaccinated against measles, she did not have IgG circulating antibodies for measles; the patient received the first dose after 15 months of age; Literature report.  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 2-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The patient received the first dose after 15 months of age. (Inappropriate age at vaccine administration). The patient was vaccinated against measles 4 months prior to presentation  The patient was admitted to the pediatric inpatient service with a 5-day history of tactile fever, with associated cough, runny nose, and rash. She had a generalized maculopapular rash initially on her face, which then spread to her trunk and extremities. Other positive findings included bilateral clear, watery eye discharge, nasal congestion, and a white enanthem noted on buccal mucosal surfaces. She was noted to be inconsolable and not soothed by her mother during examination. Differential diagnosis included scarlet fever, Kawasaki disease, and viral exanthem; however, due to the recent exposure to confirmed cases of measles, she was placed on airborne isolation precautions. Nasopharyngeal polymerase chain reaction (PCR) for measles was positive, and immunoglobulin G (IgG) measles antibody was negative, confirming an active infection (Vaccination failure, Measles antibody negative).  At the time of reporting, the outcome of Vaccination failure, and Measles antibody negative was unknown. The action taken with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  regarding Vaccination failure, Measles antibody negative was reported as Not Applicable.   The reporter considered Vaccination failure and Measles antibody negative to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  A copy of the published article is attached as further documentation of the patient's experience.  Lot # is being requested and will be submitted if received.
Age: 1.67
Sex: F
Vaccine: MMR
Symptoms: Rash maculo-papular, Rhinorrhoea, Vaccination failure
Clinical narrative: although our patient was vaccinated against measles, she did not have IgG circulating antibodies for measles; although our patient was vaccinated against measles, she did not have IgG circulating antibodies for measles; the patient received the first dose after 15 months of age; Literature report.  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 2-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The patient received the first dose after 15 months of age. (Inappropriate age at vaccine administration). The patient was vaccinated against measles 4 months prior to presentation  The patient was admitted to the pediatric inpatient service with a 5-day history of tactile fever, with associated cough, runny nose, and rash. She had a generalized maculopapular rash initially on her face, which then spread to her trunk and extremities. Other positive findings included bilateral clear, watery eye discharge, nasal congestion, and a white enanthem noted on buccal mucosal surfaces. She was noted to be inconsolable and not soothed by her mother during examination. Differential diagnosis included scarlet fever, Kawasaki disease, and viral exanthem; however, due to the recent exposure to confirmed cases of measles, she was placed on airborne isolation precautions. Nasopharyngeal polymerase chain reaction (PCR) for measles was positive, and immunoglobulin G (IgG) measles antibody was negative, confirming an active infection (Vaccination failure, Measles antibody negative).  At the time of reporting, the outcome of Vaccination failure, and Measles antibody negative was unknown. The action taken with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  regarding Vaccination failure, Measles antibody negative was reported as Not Applicable.   The reporter considered Vaccination failure and Measles antibody negative to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  A copy of the published article is attached as further documentation of the patient's experience.  Lot # is being requested and will be submitted if received.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number B4942, expiry date 06-APR-2026) for prophylaxis.   On 25-SEP-2024, the patient received the 2nd dose of Shingrix. On 25-SEP-2024, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: underdose). The outcome of the accidental underdose was unknown.   Additional Information: GSK receipt date: 25-SEP-2024 The pharmacist reported that the patient had received Shingrix dose probably half of the dose but, due the needle was not tidied enough or who knows why, which led to accidental underdose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Balance disorder, Fatigue, Myalgia, Nausea, Sleep disorder
Clinical narrative: I woke up the morning after being vaccinated and the room around me appeared (visually) to be moving, and the bed (physically) appeared to be moving. When I stood up my body did not seem to understand which direction was up/down/sideways, and I used the walls to balance myself and walk to the bathroom, where I vomited. I returned to bed and when I lay down I became nauseated again and vomited again. Repeat ad nauseam. I was able to call my pharmacist, who suggested I try to take Tylenol and drink lots of fluids. I took a Tylenol and did feel better enough to drink some water and eat some yogurt, which I then vomited. After that I could not keep down water or Tylenol at all, nor could I lay down without immediately vomiting. The vertigo abated before the nausea did. I continued to vomit bright yellow liquid (bile?) and what water I could drink until about 4:00 Sunday morning, when I was able to fall asleep sitting up, and later in the morning I was able to lie down. When I woke up there were no symptoms other than fatigue and sore muscles.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vertigo, Vomiting
Clinical narrative: I woke up the morning after being vaccinated and the room around me appeared (visually) to be moving, and the bed (physically) appeared to be moving. When I stood up my body did not seem to understand which direction was up/down/sideways, and I used the walls to balance myself and walk to the bathroom, where I vomited. I returned to bed and when I lay down I became nauseated again and vomited again. Repeat ad nauseam. I was able to call my pharmacist, who suggested I try to take Tylenol and drink lots of fluids. I took a Tylenol and did feel better enough to drink some water and eat some yogurt, which I then vomited. After that I could not keep down water or Tylenol at all, nor could I lay down without immediately vomiting. The vertigo abated before the nausea did. I continued to vomit bright yellow liquid (bile?) and what water I could drink until about 4:00 Sunday morning, when I was able to fall asleep sitting up, and later in the morning I was able to lie down. When I woke up there were no symptoms other than fatigue and sore muscles.
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Rash, Skin exfoliation
Clinical narrative: Skin rash redness flacking
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Condition aggravated, Full blood count, Metabolic function test, Palpitations
Clinical narrative: Have had many COVID boosters, never bad reaction. This one triggered my heart palpiatations causing me to visit the Hospital ED and now a subsequent visit to my cardiology office. Constant heart palpitations.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient was administered a dose of Arexvy on 05Sep2024 that had been reconstituted with sterile water (from a syringe from a Merck vaccine), instead of the supplied AS01E adjuvant; patient was administered a dose of Arexvy on 05Sep2024 that had been reconstituted with sterile water (from a syringe from a Merck vaccine), instead of the supplied AS01E adjuvant; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 80-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3Y7P4, expiry date 21-MAR-2025) for prophylaxis.   On 05-SEP-2024, the patient received Arexvy. On 05-SEP-2024, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient was administered a dose of Arexvy on 05Sep2024 that had been reconstituted with sterile water (from a syringe from a Merck vaccine), instead of the supplied AS01E adjuvant) and inappropriate dose of vaccine administered (Verbatim: patient was administered a dose of Arexvy on 05Sep2024 that had been reconstituted with sterile water (from a syringe from a Merck vaccine), instead of the supplied AS01E adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-SEP-2024 The nurse reported that the patient was administered a dose of Arexvy that had been reconstituted with sterile water (from a syringe from a Merck vaccine) instead of the supplied AS01E adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. At the time of reporting, no further doses had been administered. The Vaccine Administration Facility was the same as Primary Reporter