chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received bnt162b2 (BNT162B2 NOS), on 02Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "Allergy". On an unspecified date, the patient experienced of COVID-19. Covid symptoms went away on the medicine but came back 12 hours after I stopped the medicine. Sore throat then runny nose. Then cough four days later. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 17Sep2023 to 22Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), in Jun2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. Vaccine administration time reported as 02:00 PM. The patient's relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID (lot number reported as 00069-1085-30) as treatment of COVID-19 from 17Sep2023 to 21Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccines BNT162B2, BNT162B2 OMI BA.4-5, BNT162b2 cannot be completely excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 13:15 as dose 5 (booster), single (Lot number: Gh9702) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 002A21A), in left arm, on 31Mar2021 as dose 2, single (Lot number: 007B21A), in left arm, on 24Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in left arm and on 22Jul2022 as dose 4 (booster), single (Lot number: 017B22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 58-year-old male patient received bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ep6955) and on 12Apr2021 as dose 2, single (Lot number: ep6955) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "CNS Lyme Disease" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID 19 Treatment on 22Sep2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2 cannot be completely excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: CH9402) at the age of 69 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: NDC 59267-1000-1), in left arm, on 28Mar2021 as dose 2, single (Lot number: NDC59267-1000-1), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: FF3592), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: 33130BA), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test for 2 more weeks; Positive, notes: positive test for 2 more weeks; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID from 07Sep2023 to 11Sep2023.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: my blood sugars are very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (ongoing), notes: I am diabetic. The patient's concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 21Sep2023, outcome "unknown", described as "my blood sugars are very high". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased. Additional information: A couple of days ago, the patient had a Pfizer shot, a COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine and the patient had a couple side effects that would like to report. Since, the patient had the shot (COVID-19 Vaccine) on Thursday; the 21Sep2023 blood sugars were very high and the patient had to put more Insulin. The patient was diabetic. The patient took 4 shot of Insulin a day and blood sugars were high, was this shot affecting blood sugar? The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt very achy all over her body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Sep2023, outcome "unknown", described as "felt very achy all over her body".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2023, outcome "unknown", described as "had an allergic reaction".  Additional information: The reporter mentioned she go the new Pfizer COVID-19 vaccine yesterday (20Sep2023) and had an allergic reaction. She was wondering if it contains any seafood, shellfish, or anything like that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV
Symptoms: Drug ineffective, Respiratory syncytial virus infection
Clinical narrative: already been hospitalized once with RSV; already been hospitalized once with RSV; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID:.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization, medically significant), outcome "unknown" and all described as "already been hospitalized once with RSV".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine ABRYSVO administration.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to metals
Clinical narrative: has an allergy to mercury; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID.  A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO METALS (non-serious), outcome "unknown", described as "has an allergy to mercury".  Additional information: Caller, from a pharmacy, has a patient there, 72 years old, that wants the Prevnar 20 vaccine. She previously had the Prevnar 13 and has an allergy to mercury. Caller wants to be sure she can give the vaccine with a mercury allergy.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein), pneumococcal 13-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Throat tightness
Clinical narrative: Anaphylactic reaction; Throat started to close up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001166 (Novavax).  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose number unknown, Single). The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown"; THROAT TIGHTNESS (medically significant), outcome "unknown", described as "Throat started to close up".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296723 same reporter/patient/drug, different dose/AE;
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Immunodeficiency
Clinical narrative: immunocomprise; COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocomprise"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". Clinical course: Caller mentioned that in the beginning of the pandemic, he joined the COVID study where he took the vaccine and was paid for it. He is on social security and pays him using the card. He did two different studies; he wants to get a printout on how he was paid and the time frame. Precautionary AE form created since he has COPD and immunocomprised.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: inadvertent administration of IPOL that was not supported by the extended stability information post excursion with no adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA286823.  This case involves a 4 year old female patient who had inadvertent administration of IPV (VERO) [IPOL] that was not supported by the extended stability information post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Prophylactic vaccination (immunization).  On 12-Sep-2023, the patient received a dose 4 dose 0.5 ml of suspect IPV (VERO) Suspension for injection lot V1B891M expiry date: 01-jun-2024 via intramuscular route in the left thigh for Immunization and inadvertent administration of ipol that was not supported by the extended stability information post excursion with no adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertent administration of ipol that was not supported by the extended stability information post excursion with no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: previously reported temperature excursion for menquadfi with no reported adverse event; after temperature excursion clinic did administer a dose of the menquadfi to a patient with no reported adverse event; Initial information was received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 11 years old male patient who reported that previously reported temperature excursion for menquadfi with no reported adverse event and after temperature excursion clinic did administer a dose of the menquadfi to a patient with no reported adverse event after receiving meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Sep-2023, the patient received a dose 1 of 0.5 ml of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) (lot U7633AB, Expiry date :25-Apr-2025, strength was unknown) via intramuscular route in the right deltoid for Immunization.  On 15-Sep-2023 the patient previously reported temperature excursion for menquadfi with no reported adverse event (product storage error) and after temperature excursion clinic did administer a dose of the menquadfi to a patient with no reported adverse event (poor quality product administered) (latency : same day) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event previously reported temperature excursion for menquadfi with no reported adverse event and was Unknown for the event after temperature excursion clinic did administer a dose of the menquadfi 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 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.  Additional information was received on 21-Sep-2023 from Other health care professional : Correspondent reporter, Patient initials, therapy start date, dosage, dose number, route, events were added. Case was upgraded from Non case to valid. Text amended accordingly.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: patient was administered with expired Pentacel with no reported adverse event; Initial information received from on 19-Sep-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 months old female patient where patient was administered with 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 rotavirus vaccine for Prophylactic vaccination.  On 19-Sep-2023, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot- UJ737AAA and expiration date- 18-Sep-2023) via intramuscular route in the left thigh (strength: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was unknown on an unknown date 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.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: was given with the regular flu vaccine Fluzone QIV rather than the Fluzone high dose flu vaccine with no adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Elderly patient of an unknowm age and gender who was given with the regular flu vaccine Influenza Quadrival A-B Vaccine [Fluzone Qiv] rather than the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no 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 an unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (with an unknown expiry date, lot number, strength) via unknown route in unknown administration site for Immunization.  On an unknown date, the patient was given with the regular flu vaccine Influenza Quadrival A-B Vaccine rather than the Influenza Quadrival A-B High Dose Hv Vaccine with no adverse event (wrong product administered) (latency: same day).  It was reported, A Pharmacy Director/ Pharmacist said they have a patient on one of their site who is over 65-years-old and was given with the regular flu vaccine Fluzone QIV rather than the Fluzone high dose flu vaccine. Inquirer asked if they have to revaccinate the patient with the high dose flu vaccine.  She does not have any information on the lot number or the age or gender of the patient, but states that since it was a flu shot clinic, no other vaccines were given. They will contact the patient and refer them to their HCP to determine follow-up actions, if any. Pharmacist states that she instructed staff on duty to fill out a VAERS report.   Action taken: not applicable  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 48.0
Sex: M
Vaccine: DTAP, TD
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: patient received an expired dose of tenivac, when he was suppose to receive a dose of Tdap with no reported adverse event; patient received an expired dose of tenivac, when he was suppose to receive a dose of Tdap with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 48 years old male patient who received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac], when he was supposed to receive a dose of Diphtheria, Tetanus And Acellular Pertussis Vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Sep-2023, the patient received a dose 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection lot U7092AA expiry date: 24-Jun-2023 via intramuscular route in the deltoid not specified for prophylactic vaccination (immunization) and patient received an expired dose of tenivac, when he was supposed to receive a dose of Diphtheria, Tetanus And Acellular Pertussis Vaccine with no reported adverse event (expired product administered) (wrong product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4-month-old patient was administered with adacel with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient to whom adacekl was given with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 15V (CRM197)) for Immunisation.  On 20-Sep-2023, 4 month old patient received 0.5 ml, once suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE,Suspension for injection lot U7869AA via intramuscular route in the right thigh for prophylactic vaccination (strength and expiry date: unknown) (product administered to patient of inappropriate age) (latency same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 4-month-old patient was administered with adacel 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 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: FLU4
Symptoms: Pain in extremity, Swelling
Clinical narrative: swelling; soreness on the arm; flare-ups after receiving the vaccine; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2023SA289922(Cluster).  This case involves an unknown age and unknown gender patient who experienced swelling, soreness on the arm and flare-ups after receiving the vaccine after receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot- UT8055NA) via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation.  On an unknown date the patient developed swelling, soreness on the arm (pain in extremity) and flare-ups after receiving the vaccine (condition aggravated) (unknown latency) following the administration of influenza quadrival a-b vaccine.  Report about 2 patients who had an adverse reaction to the vaccine. One patient experienced having sore throat and difficulty swallowing after receiving the vaccine while another another patient reported swelling and soreness on the arm and flare-ups after receiving the vaccine.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: they have administered ACTHIB that has expired on 11Sep2023 to a patient today with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 years old male patient who was administered Haemophilus Type B (Hib) Vaccine (ACT-HIB) that has expired on 11sep2023 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 A Vaccine (Hepatitis A Vaccine) for Prophylactic vaccination.  On 20-Sep-2023, the patient received 0.5 ml (Dose 4) of suspect Haemophilus Type B (Hib) Vaccine Powder and solvent for solution for injection (lot number: UJ798AB) (Expiry date: 11-Sep-2023) via unknown route in unknown administration site for Immunization.  On 20-Sep-2023 the patient was administered Haemophilus Type B (Hib) Vaccine (ACT-HIB) that has expired on 11sep2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, Physician asks if there is a grace period for expired ACTHIB, and if there are dosing recommendations for re-vaccination after they have administered ACTHIB that has expired on 11Sep2023 to a patient today 20Sep2023. This situation is reported as a medication error due to a patient was administered with expired ACTHIB.   Action taken: not applicable.  Outcome: Recovered / Resolved on an unknown date 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: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling on the inner right arm toward the elbow; redness on the inner right arm toward the elbow; Initial information received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2023SA291592 (CLUSTER).  This case involves a 71 years old female patient who had swelling on the inner right arm toward the elbow and redness on the inner right arm toward the elbow after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines administered.  On 19-Sep-2023, the patient received a total dose of 0.7 ml of suspect influenza quadrival A-B high dose HV vaccine prefilled syringe (lot U8130DA, expiry date- 30-JUN-2024) via intramuscular route in the right deltoid for Immunization.  On 21-SEP-2023, (latency- 2 days), the patient developed swelling on the inner right arm toward the elbow (peripheral swelling) and redness on the inner right arm toward the elbow (erythema) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, The reaction is on the same arm that the vaccine was given, but not technically at the injection site, but it is above the elbow on the same arm. Patient has not experienced any fever.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patient has developed swelling on the inner left arm toward the elbow; patient has developed redness on the inner left arm toward the elbow; Initial information was received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2023SA291630 (CLUSTER).  This case involves 71 years old male patient has developed swelling on the inner left arm toward the elbow and patient has developed redness on the inner left arm toward the elbow after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines administered.  On 19-Sep-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival A-B high dose HV vaccine (Frequency : Total, lot U8130DA, strength, expiry date, formulation unknown) via intramuscular route in the left deltoid for Immunization.  On 21-Sep-2023 the patient developed swelling on the inner left arm toward the elbow (peripheral swelling) and developed redness on the inner left arm toward the elbow (erythema) (latency : 2 days) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly "The reaction is on the same arm that the vaccine was given, but not technically at the injection site, but it is above the elbow on the same arm. A husband and wife have reported the same reaction. Patient has not experienced any fever."  Action taken with quadrivalent influenza vaccine (fluzone high-dose quadrivalent) was not applicable.  It was not reported if the patient received a corrective treatment for the events (patient has developed swelling on the inner left arm toward the elbow, patient has developed redness on the inner left arm toward the elbow).  At time of reporting, the outcome was Not Recovered for the events patient has developed swelling on the inner left arm toward the elbow and patient has developed redness on the inner left arm toward the elbow.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: MA incorrectly administered MENQUADFI which is for 2 years of age and older with no adverse event; a 2-month-old patient should be given VAXELIS but MA incorrectly administered MENQUADFI with no adverse event; Initial information received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2-months-old male patient who was incorrectly administered meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] which is for 2 years of age and older instead of diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3V (vero), tetanus vaccine toxoid [Vaxelis] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the 2-months-old patient received unknown dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7632BB; expiry date: 14-Apr-2025) instead of Vaxelis not produced by Sanofi Pasteur (formulation, batch number and expiry date unknown) via unknown route in unknown administration site for immunization with no adverse event (product administered to patient of inappropriate age) (wrong product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Tremor
Clinical narrative: Uncontrolled body shaking N/A
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: About 30 minutes to an hour after getting the injection the site started itching & was red, hot to the touch & raised in an area about the size of a quarter. 35 hours later the redness, swelling, itchiness & heat are still there but has grown to the size of a silver dollar. Under the skin is a big lump. It's only painful to the touch.
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Injection site warmth
Clinical narrative: About 30 minutes to an hour after getting the injection the site started itching & was red, hot to the touch & raised in an area about the size of a quarter. 35 hours later the redness, swelling, itchiness & heat are still there but has grown to the size of a silver dollar. Under the skin is a big lump. It's only painful to the touch.
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: About 30 minutes to an hour after getting the injection the site started itching & was red, hot to the touch & raised in an area about the size of a quarter. 35 hours later the redness, swelling, itchiness & heat are still there but has grown to the size of a silver dollar. Under the skin is a big lump. It's only painful to the touch.
Age: 44.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Severe headaches that Tylenol did not help with the pain. Chills. Arm soreness
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Condition aggravated, Diarrhoea, Gastrooesophageal reflux disease, Nausea
Clinical narrative: 1. Tinnitus- loud metal banging and hollow echo sounds ( like being inside a tin can) in both ears. Began almost exactly 12 hours after my vaccine at the same time other ?typical? side effects that I have experienced with previous vaccine doses such as fever and muscle aches began. While other regular side effects resolved after 36 hours the tinnitus continues 4 days later although the severity and frequency seems to be getting reduced.   2. GERD, Stomach pains and diarrhea- I have GERD normally controlled by medication but the vaccine always exacerbates it and beginning 12 hours after my vaccine for 24 hours my GERD was extremely bad and the medication was not even touching it. I also had some nausea during that time period which I have not had with the COVID vaccines previously. Then on day 4 post vax I suffered from stomach pains and diarrhea for about 12 hours. I have been eating a bland diet since the vaccine trying to calm down my GERD so nothing in the food I have eaten explains the diarrhea or it?s relatively sudden onset and resolution within 12 hours.   3. Fever- began 12 hours after vaccine. Peaked at 101.8 about 14 hours after vaccine, and remained there until 24 hours after vaccine at which point it dropped to about 100.4 for another 12 hours before returning to normal at about 36 hours post vax. I have had a fever with all both dose #1 but this was one of the higher fevers, similar to fever experienced with dose #2 of primary series. U
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: 1. Tinnitus- loud metal banging and hollow echo sounds ( like being inside a tin can) in both ears. Began almost exactly 12 hours after my vaccine at the same time other ?typical? side effects that I have experienced with previous vaccine doses such as fever and muscle aches began. While other regular side effects resolved after 36 hours the tinnitus continues 4 days later although the severity and frequency seems to be getting reduced.   2. GERD, Stomach pains and diarrhea- I have GERD normally controlled by medication but the vaccine always exacerbates it and beginning 12 hours after my vaccine for 24 hours my GERD was extremely bad and the medication was not even touching it. I also had some nausea during that time period which I have not had with the COVID vaccines previously. Then on day 4 post vax I suffered from stomach pains and diarrhea for about 12 hours. I have been eating a bland diet since the vaccine trying to calm down my GERD so nothing in the food I have eaten explains the diarrhea or it?s relatively sudden onset and resolution within 12 hours.   3. Fever- began 12 hours after vaccine. Peaked at 101.8 about 14 hours after vaccine, and remained there until 24 hours after vaccine at which point it dropped to about 100.4 for another 12 hours before returning to normal at about 36 hours post vax. I have had a fever with all both dose #1 but this was one of the higher fevers, similar to fever experienced with dose #2 of primary series. U
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Nausea, Presyncope
Clinical narrative: Severe headache, nausea, near syncope when standing
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Subdural haematoma
Clinical narrative: intracranial subdural hematoma
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood magnesium, Dysstasia, Full blood count, Hypoaesthesia, Metabolic function test
Clinical narrative: Patient received COVID-19 booster 9/26/2023 morning and initially had no complaints or side effects. Upon awakening 9/27/23 morning he was unable to stand. Patient brought to ED by EMS, paramedic reports that patient was able to stand w/ 2-person assistance only. Patient denies pain and reports numbness to both legs.  He denies any other concerning symptoms of illness such as fever or chills or nausea or vomiting.  He does not have any difficulty breathing or any chest pain.  He denies any pain in the legs but does report some possible decreased sensation generally. After he got the shot yesterday he states he did feel well and was up and walking using his cane. He reports a remote history of possibly having similar symptoms after a previous COVID booster shot as well.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss, Urine analysis, Walking aid user
Clinical narrative: Patient received COVID-19 booster 9/26/2023 morning and initially had no complaints or side effects. Upon awakening 9/27/23 morning he was unable to stand. Patient brought to ED by EMS, paramedic reports that patient was able to stand w/ 2-person assistance only. Patient denies pain and reports numbness to both legs.  He denies any other concerning symptoms of illness such as fever or chills or nausea or vomiting.  He does not have any difficulty breathing or any chest pain.  He denies any pain in the legs but does report some possible decreased sensation generally. After he got the shot yesterday he states he did feel well and was up and walking using his cane. He reports a remote history of possibly having similar symptoms after a previous COVID booster shot as well.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Headache
Clinical narrative: Sore shoulder and doll headache
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Confirmed no additional AE; HCP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. The product expired on 08/29/2023 and was administered on 09/02/2023. Limited patient demographics provided. Confirmed no additional AE/PQC.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.    On 02-SEP-2023, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 mL (lot # U032086, expiration date: 29-AUG-2023) (route of administration, anatomical location not provided) as prophylaxis. It was confirmed that no additional adverse events were reported.  Follow-up information was received from the pharmacist on 25-SEP-2023. The patient's identifiers were updated. The patient was a 46-year-old female. It was reported that the patient "was doing OK" and did not had adverse event. The reporter was not comfortable providing any additional patient information at the time.