chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose of Engerix-B was given to an adult patient; Adult use of child product; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 25-year-old female patient who received HBV (Engerix B pediatric) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis.   On 21-SEP-2023, the patient received Engerix B pediatric. On 21-SEP-2013, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Adult use of child product). On 21-SEP-2023, the patient experienced underdose (Verbatim: pediatric dose of Engerix-B was given to an adult patient).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2023 The Nurse called to report a pediatric dose of Engerix-B was given to an adult patient, which led to underdose and adult use of a child product The reporter did not consent to follow-up.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: accidentally gave an expired dose of Fluarix from last flu season; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (expiry date 30-JUN-2023) for prophylaxis.   On 22-SEP-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 22-SEP-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: accidentally gave an expired dose of Fluarix from last flu season).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Sept-2023 Nurse stated that a staff member accidentally gave an expired dose of Fluarix from last flu season.  The clinic does not had Fluarix in private stock for this season but the staff member was not aware of this and found an old dose in the back of the vaccine fridge which was administered to the patient on the day of reporting. No further details provided on the call. Consent granted for safety to follow up.  The patient received an expired dose of Fluarix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Fatigue, Pyrexia
Clinical narrative: Weird metallic taste; Tiredness; Fever; Pateint received 1st dose on 19-sep-22 and 2nd dose on 11-sep-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of taste metallic in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th July 2022).   On 11-SEP-2023, the patient received the 2nd dose of Shingrix (left arm). On 11-SEP-2023, less than a day after receiving Shingrix, the patient experienced taste metallic (Verbatim: Weird metallic taste), tiredness (Verbatim: Tiredness), fever (Verbatim: Fever) and drug dose administration interval too long (Verbatim: Pateint received 1st dose on 19-sep-22 and 2nd dose on 11-sep-2023). The outcome of the taste metallic was not resolved and the outcome of the tiredness and fever were resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the taste metallic, tiredness and fever to be related to Shingrix.     It was unknown if the company considered the taste metallic, tiredness and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-SEP-2023 The patient was self-reported this case. The reporter reported that she received Shingrix vaccine and experienced fever 100 degree F and tiredness the same night and also a weird metallic taste in her mouth.  The reporter stated that the fever and tiredness went away but the metallic taste persists until today. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: small amount of the Shingrix leaked out onto the patients arm; small amount of the Shingrix leaked out onto the patients arm; small amount of the Shingrix leaked out onto the patients arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 85-year-old male patient who received Herpes zoster (Shingrix) (batch number cr3s5) for prophylaxis.   On 18-SEP-2023, the patient received Shingrix (intramuscular). On 18-SEP-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: small amount of the Shingrix leaked out onto the patients arm), inadvertent exposure to vaccine (Verbatim: small amount of the Shingrix leaked out onto the patients arm) and exposure via skin contact (Verbatim: small amount of the Shingrix leaked out onto the patients arm).The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter who stated while given the vaccine to the patient while withdrawing the needle small amount of the Shingrix leaked out onto the patients arm, which led to incomplete dose administered, inadvertent exposure to the vaccine and exposure via skin contact. No harm was done during this and pharmacist not complained of any other adverse event via the patient.  The reporter was warm transferred to the Vaccine Service Center for further questions.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling cold, Myalgia, Peripheral coldness
Clinical narrative: Fingertips are cold; Muscle pain in hip area; Feel super cold; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold hands in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-SEP-2023, the patient received the 1st dose of Shingrix. On 21-SEP-2023, 3 days after receiving Shingrix, the patient experienced cold hands (Verbatim: Fingertips are cold), muscle pain (Verbatim: Muscle pain in hip area) and feeling cold (Verbatim: Feel super cold).  The outcome of the cold hands, muscle pain and feeling cold were unknown.   It was unknown if the reporter considered the cold hands, muscle pain and feeling cold to be related to Shingrix.     It was unknown if the company considered the cold hands, muscle pain and feeling cold to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter reported that the patient received Shingrix vaccine on Monday, and on last night 21st September 2023 experienced to feel super cold, her fingertips are really cold and had muscle pain in the hip area. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she had her first Shingrix vaccination 3-4 years ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st Shingrix vaccination 3 to 4 years ago).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she had her first Shingrix vaccination 3-4 years ago).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-SEP-2023 Consumer was the reporter stated she had her 1st Shingrix vaccination 3 to 4 years ago no further information was known, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix to patient that will be 4 yoa/Vaccine will possibly be administered today; Kinrix to patient that will be 4 yoa/Vaccine will possibly be administered today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 3-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Kinrix to patient that will be 4 yoa/Vaccine will possibly be administered today) and inappropriate age at vaccine administration (Verbatim: Kinrix to patient that will be 4 yoa/Vaccine will possibly be administered today).The outcome of the circumstance or information capable of leading to medication error and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter would like to know if she could administer the Kinrix to patient that would be 4 years old on 23rd September 2023, which led to circumstance or information capable of leading to medication error and inappropriate age at vaccine administration. The vaccine would possibly be administered at the time of reporting.  It was not administer prior to call. The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: cold and Pharmacist noticed that it was half frozen; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product storage error in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number C2PH4, expiry date 30-JUN-2024) for prophylaxis.   On 21-SEP-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced product storage error (Verbatim: cold and Pharmacist noticed that it was half frozen).  The outcome of the product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2023 The pharmacist reported that while administering Fluarix the patient said it was cold and Pharmacist noticed that it was half frozen, which led to Product storage error. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: 3rd dose of Shingrix was inadvertently administered; dose 2 on 7/28/2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 3B2YJ, expiry date 16-AUG-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th October 2019).   On 22-SEP-2023, the patient received the 3rd dose of Shingrix. On 28-JUL-2020, the patient received the 2nd dose of Shingrix. On 28-JUL-2020, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: dose 2 on 7/28/2020). On 22-SEP-2023, the patient experienced extra dose administered (Verbatim: 3rd dose of Shingrix was inadvertently administered).  The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 22-SEP-2023 The pharmacist stated a 3rd dose of Shingrix was inadvertently administered.  The patient had received 1st and 2nd (which was also a late dose).  The first 2 doses were administered at another pharmacy. The vaccine administration facility was the same as primary reporter. The patient received late 2nd dose, which led to lengthening of dose schedule. The patient was administered with 3rd dose, which led to extra dose administration.  The reporter consented to follow up via postal.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix outside of age range; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis.   On 22-SEP-2023, the patient received the 1st dose of Pediarix. On 22-SEP-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Pediarix outside of age range).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2023 The nurse called in to request information on how to continue the series after a patient over 12 received first dose of Pediarix. They provided information about vaccine event and patient. The reporter consented to follow up. The patient over 12 years old received a dose of Pediarix, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: RSV
Symptoms: Illness, Productive cough, Respiratory syncytial virus infection, Upper respiratory tract infection, Vaccination failure
Clinical narrative: bad cough, still has mucus coming up; Upper Respiratory Infection; Suspected Vaccination failure; RSV; Sick; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma.   In AUG-2023, the patient received Arexvy. On 03-SEP-2023, between 2 and 4 weeks after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV) and sickness (Verbatim: Sick). On an unknown date, the patient experienced productive cough (Verbatim: bad cough, still has mucus coming up) and upper respiratory tract infection (Verbatim: Upper Respiratory Infection).  The patient was treated with ciprofloxacin (Cipro). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection, sickness, productive cough and upper respiratory tract infection were not resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, sickness, productive cough and upper respiratory tract infection to be related to Arexvy.     It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection, sickness, productive cough and upper respiratory tract infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-SEP-2023 Customer was a female patient that received the Arexvy vaccine the 3rd week of August, 2023 (no specific date provided) and reported that she had been sick for a month, beginning 3-SEP-2023 through today had RSV, which was diagnosed by a doctor with an upper respiratory infection, a bad cough, and still had mucus coming up. Customer said she had been debilitated from having RSV, and was taking Cipro twice a day (unknown product information) to keep from getting pneumonia. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming RSV were unknown at the time of reporting.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered
Clinical narrative: report only the diluent portion of Arexvy was administered to a patient without the lyophilized component; report only the diluent portion of Arexvy was administered to a patient without the lyophilized component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2B775, expiry date 13-DEC-2024) for prophylaxis.   On 23-SEP-2023, the patient received Arexvy. On 23-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate dose of vaccine administered (Verbatim: report only the diluent portion of Arexvy was administered to a patient without the lyophilized component) and inappropriate preparation of medication (Verbatim: report only the diluent portion of Arexvy was administered to a patient without the lyophilized component).  The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 The pharmacist reported patient was administered only the diluent portion of Arexvy without the lyophilized component which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The details patient and vaccine were asked and declined because reporter stated was not at the facility now of call. Reporter stated patients age to be 80 or 90 but was not sure about the exact age . The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Diarrhoea
Clinical narrative: Uncontrollable diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Uncontrollable diarrhea) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F234) for COVID-19 prophylaxis.     Concurrent medical conditions included ALS.    In September 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced DIARRHOEA (Uncontrollable diarrhea). At the time of the report, DIARRHOEA (Uncontrollable diarrhea) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  On 23 March 2021, Patient took Moderna COVID-19 vaccine with batch lot number 044A21A, On 23 April 2021 took with lot number 036B21A and on 06 December 2021 took with lot number 017F21A respectively.   She was her husband's caregiver who had ALS and had bad reactions to Spikevax, uncontrollable diarrhea. Had the vaccine 6 pm on Friday and started that evening between 1-3 am and was happening every 2 hours. It slowed down, but just happened on 25 September 2023.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.
Sex: M
Vaccine: UNK
Symptoms: Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (UTI) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient took Moderna vaccine and believes he had UTI. Patient took doctor's appointment and wanted to know if taking antibiotics they may prescribe him will interact with the vaccine or not. Treatment medication was provided.
Sex: M
Vaccine: FLUX
Symptoms: Cerebrovascular accident
Clinical narrative: had one friend in his early 50s, healthy until he got the first shot, 2 strokes since; Initial information was received on 23-Sep-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-health-care professional.  This case involves an unknown age male patient who had one friend in his early 50s, healthy until he got the first shot, 2 strokes since after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, expiry date, strength, formulation not reported) via unknown route in unknown administration site for prophylactic vaccination(Immunization). The information on batch number was requested.  On an unknown date the patient developed had one friend in his early 50s, healthy until he got the first shot, 2 strokes since (cerebrovascular accident) (unknown latency) following the administration of influenza vaccine.    It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (had one friend in his early 50s, healthy until he got the first shot, 2 strokes since).  At time of reporting, the outcome was Unknown for the event had one friend in his early 50s, healthy until he got the first shot, 2 strokes since.  Seriousness Criteria : This event was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 28-Sep-2023 : This case involves an unknown age male patient who had one friend in his early 50s, healthy until he got the first shot, 2 strokes since after receiving vaccine influenza vaccine. Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, 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: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: medication error due to administering an expired vaccine to a patient with no reported adverse event; Initial information was received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an infant of (<1 year enter as 2m, 4m) and unknown gender patient who experienced medication error due to administering an expired vaccine  hib (prp/t) vaccine [ACT-HIB] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.5 ml of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization. The information on batch number was requested.  On an unknown date the patient had medication error due to administering an expired vaccine to a patient with no reported adverse event (expired product administered) (latency: same day).  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event medication error due to administering an expired vaccine to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: given an additional Fluzone vaccine by accident with no reported adverse event; Initial information received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves an unknown age and unknown gender patient who was given an additional influenza quadrival A-B MULTIDOSE vaccine preserved [Fluzone] vaccine by accident with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b multidose vaccine preserved Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (extra dose administered) (unknown latency).Information on the batch number was requested.  Patient that was given an additional Fluzone vaccine by accident. 2 days prior, the patient already got the 1st Fluzone vaccine dose.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 0.33
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired PENTACEL was administered to a patient with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 months old female patient who was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination (Immunisation); and rotavirus vaccine live oral 1V (Rotarix) for Prophylactic vaccination (Immunisation).  On 21-Sep-2023, the patient received a standard expired dose 2 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ788AAA, expiry date- 18-SEP-2023) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller asks what should they do? She asks how they should document the expired dose in the chart?   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD QIV vaccine was administered to a 25 year old patient with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 25 years old male patient who was administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] 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-2023, the 25 year old patient was administered a standard dose of suspect influenza quadrival A-B high dose HV vaccine (with an unknown formulation) at a dose of 0.7mL once (lot UT8079DA, expiry date- 30-JUN-2024) via intramuscular route in the right arm for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Caller asked guidance on this.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia Episode occurred 24hrs following Covid vaccine 9/27/2023.
Age: 46.0
Sex: F
Vaccine: FLUR4
Symptoms: Abdominal pain upper, Chills, Headache, Insomnia, Pyrexia
Clinical narrative: Fever, chills, headache, stomach cramps, insomnia  Started at 11:00 pm and is still happening at 4:30 am
Age: 56.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired Td. Vaccine had expired one day prior to administration.
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: pt received flu shot . felt lightheaded and passed out
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: After 32 days from receiving the COVID booster shot i had a stroke. booster given 12/15/2021 stroke 1/17/2022. Moderna lot #045J21A, 2nd booster shot given 3/2/23 Moderna lot #066H22A another stroke 4/7/2023.
Sex: F
Vaccine: RSV
Symptoms: Chills, Fatigue, Headache, Injection site bruising, Injection site pain
Clinical narrative: Received the Arexvy RSV vaccine from the pharmacy. Injection went well with a slight soreness at injection site. In the middle of the night, woke up with chills especially my feet felt very cold. Wrapped up in a blanket but didn't get up to take my temperature to see if I had a fever. Next morning woke up with a headache and extreme tiredness. By the following day was feeling much better. Over a week later and still some soreness in my arm by the injection site and still have a bruise.
Sex: F
Vaccine: RSV
Symptoms: Peripheral coldness, Sleep disorder
Clinical narrative: Received the Arexvy RSV vaccine from the pharmacy. Injection went well with a slight soreness at injection site. In the middle of the night, woke up with chills especially my feet felt very cold. Wrapped up in a blanket but didn't get up to take my temperature to see if I had a fever. Next morning woke up with a headache and extreme tiredness. By the following day was feeling much better. Over a week later and still some soreness in my arm by the injection site and still have a bruise.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fibrin D dimer increased, Headache, Hyperhidrosis, Nausea
Clinical narrative: Moderna 2023-23 12 yr+ SYR use for COVID-19 under Emergency Use Authorization (EUA): mimic heart attack, chest comfot, nausea, vomiting, BP 219-73 elevated troponin and d-domer, profuse sweating, headache
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased, Vomiting
Clinical narrative: Moderna 2023-23 12 yr+ SYR use for COVID-19 under Emergency Use Authorization (EUA): mimic heart attack, chest comfot, nausea, vomiting, BP 219-73 elevated troponin and d-domer, profuse sweating, headache
Sex: F
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: Email received on 9/25/2023 at 12:13PM from Merck Employee with an AE/PQC report for GARDASIL 9. Email verbatim: "My daughter went to get her second Gardasil injection on Friday afternoon and the syringe failed to deliver the; Product use issue; Circumstance or information capable of leading to medication error; No other AE/PQC.; This spontaneous report was received from Company Representative and refers to a female patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-SEP-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 25-SEP-2023 at 12:13 pm, email was received from Merck Employee with an AE/PQC report for GARDASIL 9. Email verbatim: "My daughter went to get her second Gardasil injection on Friday afternoon and the syringe failed to deliver the entire dose of the drug. The nurse went to consult with the doctor and the rest of the dose was readministered from the vial. This issue was communicated to me by my spouse and daughter so I wasn't physically present for the appointment. Thus, I'm not sure if this was user error or if the doctor's office used a faulty syringe but wanted to make you aware of the situation. Happy to follow-up with the team if additional information is required." See attached. Company awareness date reflects the date the email was received. Employee did not specify when he received this information. Employee did not say if product is available for retrieval or if pictures of the product are available. Will follow up with the employee. No other AE/PQC. HCP called back in response to voice message request to follow up with AE/PQC details. HCP stated that they were unaware of this event. HCP confirmed that the documentation of reported encounter states that "0.5ml dose of GARDASIL 9 was administered to patient on 22-SEP-2023." HCP confirmed that they will follow up with the Nurse that administered the dose to the patient for additional details and will call back to determine if event was user error or PQC.
Sex: U
Vaccine: CHOL
Symptoms: Vomiting
Clinical narrative: Threw up; A spontaneous report was received from registered nurse on 07SEP2023 regarding a patient of unknown age and gender who "threw up" (PT: Vomiting) following the administration of Vaxchora (cholera vaccine live oral; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient threw up about one hour after receiving Vaxchora.  The outcome of the reported event was unknown.  The action taken with Vaxchora with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient received Vaxchora and he threw up (vomiting) an hour later. Considering the limited case information, the role of Vaxchora cannot be ruled out and the causality of vomiting is assessed as possible. The case is considered non serious as per medical assessment.  Significant follow-up information was received from the nurse on 19SEP2023.  It was reported that the patient did not have any disease and was completely healthy. The patient was allergic to penicillin.  On 01SEP2023, the patient received Vaxchora and threw up after 4-5 hours of Vaxchora administration. Reportedly, the patient vomited only once, and no treatment was provided for the same.  The patient recovered from the reported event on 01SEP2023.  Company comment: It was reported that a patient received Vaxchora and he threw up (vomiting) after 4-5 hours. Considering the limited case information, the role of Vaxchora cannot be ruled out and the causality of vomiting is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient received Vaxchora and he threw up (vomiting) after 4-5 hours. Considering the limited case information, the role of Vaxchora cannot be ruled out and the causality of vomiting is assessed as possible. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: COVID19, DTPPVHBHPB, PNC13, RV5
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given Moderna Bivalent Pink cap as first dose. Patient will be revaccinated.; No known symptoms; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID. The original narrative from the sender is the following:  "Patient was given Moderna Bivalent Pink cap, as first dose. No known symptoms. Patient will be revaccinated. Primary case provider called and advised parents of the incident".  The causal relationship between Vaxelis and the events "Patient was given Moderna Bivalent Pink cap as first dose. Patient will be revaccinated" and "No known symptoms" was assessed as not applicable due to the nature of these reported events.  Of note, these events do not concern Vaxelis, but rather COVID19 vaccination. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS.  No further information is expected. is not working, added State under vaccine facility information and Reporter State.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Pallor, Syncope
Clinical narrative: My son became very pale, said he couldn't see, and then fainted.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Chest discomfort, Cough, Lacrimation increased, Respiratory tract congestion, Wheezing
Clinical narrative: Patient reported cough, congestion, and some chest tightness/wheezing and watery eyes the day following.  Self resolved over next several days.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Blister, Myalgia, Pyrexia
Clinical narrative: muscle ache, mild fever, joint soreness 9/30 at 9am hand blisters  10/2 at 8am
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Systemic-Fever-severe
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, MMR, TYP, VARCEL
Symptoms: Back pain, Blood test normal, Cardiac monitoring, Catheterisation cardiac, Chest pain
Clinical narrative: Cervical pain, upper posterior back pain, injection site pain in the upper arms started within the first hour after injections. Then mid to lower neck pain gradually continued to worsen. Symptoms advanced with severe neck and posterior chest pain, shortness of breath, fatigue, fever like symptoms with  frequent chills, sweating, nausea, vomiting into severe anterior chest sternum pain that radiated into arms. Immediately diagnosed with myocarditis and treated
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, MMR, TYP, VARCEL
Symptoms: Chills, Dyspnoea, Echocardiogram, Electrocardiogram abnormal, Fatigue
Clinical narrative: Cervical pain, upper posterior back pain, injection site pain in the upper arms started within the first hour after injections. Then mid to lower neck pain gradually continued to worsen. Symptoms advanced with severe neck and posterior chest pain, shortness of breath, fatigue, fever like symptoms with  frequent chills, sweating, nausea, vomiting into severe anterior chest sternum pain that radiated into arms. Immediately diagnosed with myocarditis and treated
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, MMR, TYP, VARCEL
Symptoms: Hyperhidrosis, Injection site pain, Myocarditis, Nausea, Neck pain
Clinical narrative: Cervical pain, upper posterior back pain, injection site pain in the upper arms started within the first hour after injections. Then mid to lower neck pain gradually continued to worsen. Symptoms advanced with severe neck and posterior chest pain, shortness of breath, fatigue, fever like symptoms with  frequent chills, sweating, nausea, vomiting into severe anterior chest sternum pain that radiated into arms. Immediately diagnosed with myocarditis and treated
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, MMR, TYP, VARCEL
Symptoms: Pain, Pain in extremity, Pyrexia, Troponin abnormal, Vomiting
Clinical narrative: Cervical pain, upper posterior back pain, injection site pain in the upper arms started within the first hour after injections. Then mid to lower neck pain gradually continued to worsen. Symptoms advanced with severe neck and posterior chest pain, shortness of breath, fatigue, fever like symptoms with  frequent chills, sweating, nausea, vomiting into severe anterior chest sternum pain that radiated into arms. Immediately diagnosed with myocarditis and treated
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Migraine, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient called medical facility to report Migraine, weakness, fever (highest temp was 102), and nausea/vomitting that began the day after her vaccination. She stated these symptoms lasted approx 4 days and fever finally broke today. She also stated that approx 2 days after vaccination, she began having pain in her Left Leg and soreness to her L foot. She denied any injuries to extremity. She stated that her left arm was sore (vaccine was administered in her L deltoid) but stated that there was no redness or swelling to site. RN counseled patient on usual side effects related to Tdap vaccination and advised patient to see PCP regarding pain/soreness to L leg/L foot. Patient verbalized understanding and agreed to contact medical facility to update on status if seen by PCP.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Patient called medical facility to report Migraine, weakness, fever (highest temp was 102), and nausea/vomitting that began the day after her vaccination. She stated these symptoms lasted approx 4 days and fever finally broke today. She also stated that approx 2 days after vaccination, she began having pain in her Left Leg and soreness to her L foot. She denied any injuries to extremity. She stated that her left arm was sore (vaccine was administered in her L deltoid) but stated that there was no redness or swelling to site. RN counseled patient on usual side effects related to Tdap vaccination and advised patient to see PCP regarding pain/soreness to L leg/L foot. Patient verbalized understanding and agreed to contact medical facility to update on status if seen by PCP.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Aggression, Underdose
Clinical narrative: Patient became combative, knocked vaccines of nurses hand, only half the dose was given.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 69.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Pain, Rash, Swelling
Clinical narrative: Soreness, swelling and rash. Soreness and swelling lasted 2 weeks and rash is still active a month later.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Myalgia, Pyrexia, Rash
Clinical narrative: Fever (101), rash, joint and muscle pain primarily in my jaw, elbows, knees and lower back, and headache. I have never had a fever and rash with the last five Covid vaccines I have received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Histamine intolerance, Hormone level abnormal
Clinical narrative: Chronic Urticaria (hives), histamine issues, hormonal issues, elevated heart rate for months as shown on oura ring, had to cut out a wide range of foods that would give histamine like or hormonal symptoms. Still have the problem now over two years later. Never had these issues before.
Age: 79.0
Sex: F
Vaccine: FLUA4
Symptoms: Cough, Dyspnoea, Headache, Respiratory rate increased
Clinical narrative: Bad headache, it was worst yesterday. It started lightening up this morning. I started breathing real bad, then I have this cough and I started coughing real bad. I start trying to breathe real fast. I started coughing hard and couldn't stop.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUC3
Symptoms: Back pain, Chromaturia, Immunisation reaction, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: please note pharmacy did not give manufacturer of FLU so what i selected might be inaccurate .  THE ADVERSE REACTION WAS TO COVID  5 shots prior version zero reaction this new formula massive reaction : 1) threw up three times  2) created major muscle spasms in my lower back & front pelvic area was in horrific pain did not sleep for two days missed family reunion . 3) pee changed color to orange 4) just started to feel normal 10.1.2023   I emailed my doctor (did not go in person ) CALLED CDC for help and called pharmacy for help
Age: 57.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUC3
Symptoms: Pelvic pain, Sleep disorder, Vomiting
Clinical narrative: please note pharmacy did not give manufacturer of FLU so what i selected might be inaccurate .  THE ADVERSE REACTION WAS TO COVID  5 shots prior version zero reaction this new formula massive reaction : 1) threw up three times  2) created major muscle spasms in my lower back & front pelvic area was in horrific pain did not sleep for two days missed family reunion . 3) pee changed color to orange 4) just started to feel normal 10.1.2023   I emailed my doctor (did not go in person ) CALLED CDC for help and called pharmacy for help
Age: 57.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUC3
Symptoms: Chromaturia, Muscle spasms, Pelvic pain, Product administration error, Sleep disorder
Clinical narrative: please note pharmacy did not give manufacturer of FLU so what i selected might be inaccurate .  THE ADVERSE REACTION WAS TO COVID  5 shots prior version zero reaction this new formula massive reaction : 1) threw up three times  2) created major muscle spasms in my lower back & front pelvic area was in horrific pain did not sleep for two days missed family reunion . 3) pee changed color to orange 4) just started to feel normal 10.1.2023   I emailed my doctor (did not go in person ) CALLED CDC for help and called pharmacy for help