chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003867.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown".  Clinical course: On 14Oct2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech Covid-19 Vaccine dose 1 for an unspecified indication. It was reported the patient had an anaphylactic reaction to the first dose of the Pfizer vaccine and did not take the second dose. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: fluzone qiv np being administered to a geriatric patient accidentally instead of fluzone high-dose quadrivalent, with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age geriatric female patient who was accidentally administered influenza quadrival A-B vaccine [fluzone QIV] instead of 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 20-Oct-2022, the geriatric patient accidentally received a dose of suspect influenza quadrival A-B vaccine (lot UT7731, formulation, strength, dose, route and administration site: unknown) for influenza instead of fluzone high-dose quadrivalent, with no reported adverse event (wrong product administered).  It was reported "The patient is requesting to know if she should be revaccinated. Caller is on her way to work and will call back when at work with safety report information".  It was unknown if there were lab data/results available.  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: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old female patient who received an expired dose of (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 21-Oct-2022, the patient received expired 0.5 ml, third dose of suspect HIB (PRP/T) VACCINE  with unknown formulation (lot UJ583AB, expiry date:15-Oct-2022) via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.17
Sex: F
Vaccine: DTAPIPV, HIBV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: QUADRACEL and mixed it with the ActHib portion of the PENTACEL with no reported adverse event; Initial information was received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 14 months old female patient to whom was given diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] and mixed it with the hib (prp/t) vaccine [ACT-HIB]  portion of the Pentacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Immunisation.  On 12-Sep-2022, the patient received a (dose 1) of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine, suspension for injection (lot C5970AA; Expiry: 27-Apr-2023) via intramuscular route in unknown administration site and dose 2  of suspect hib (prp/t) vaccine, powder and solvent for solution for injection (lot UJ672AA; Expiry: 27-Apr-2023) via intramuscular route in unknown administration site both for immunization.  It was reported that Quadracel and mixed it with the Acthib portion of the Pentacel with no reported adverse event (product preparation error) (Latency: on same day).  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: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: patient given Dtap-IPV portion of that same Pentacel with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who was given Dtap-IPV portion of that same DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 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 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 Immunisation.  On 12-Sep-2022, the patient received a fifth dose, once of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U5256AA, 27-Apr-2023) via intramuscular route in unknown administration site for immunization patient given only Dtap-IPV portion of that same Pentacel with no reported adverse event (single component of a two-component product administered) (latency: same day).  Action taken:  not applicable.  At time of reporting, the outcome was Unknown for the event patient given dtap-ipv portion of that same pentacel 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: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: residents moved while being administered the vaccine and only half the volume of the vaccine in the PFS went into the patient, with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age male patient who reported one of residents moved while being administered the vaccine and only half the volume of the vaccine in the pfs went into the patient, with no reported adverse event while 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.  On an unknown date, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (dose, formulation, strength, lot number and expiry date not reported) via unknown route in unknown administration site one of residents moved while being administered the vaccine and only half the volume of the vaccine in the pfs went into the patient, with no reported adverse event (incorrect dose administered) (unknown latency).  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.
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: ACTHIB portion of PENTACEL was not given, with no adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient to whom acthib portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was not given, 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 a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (dose, formulation, strength lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.   On an unknown date, acthib portion of pentacel was not given to patient, with no adverse event (single component of a two-component product administered) (unknown latency).   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event acthib portion of pentacel was not given, 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: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 month old patient received a dose of FLUZONE QUAD QIV with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid non-serious case received from medical assistant and physician.  This case involves a 4-month-old male patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunization; DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunization; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization; and HIB VACCINE (HIB) for Immunization.  On 24-Oct-2022, the 4-month-old patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at (unknown: formulation, strength) at dose 0.5ml once (lot: UT7683MA, expiry date: 30-Jun-2023) via intramuscular route in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) at same day latency.  Action taken: Not applicable.  No corrective treatment was received for the event.  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: 9.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was administered the IPOL that was expired with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 years old male patient who was administered the IPV (VERO) [IPOL] that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 24-Oct-2022, the patient was administered 0.5 ml dose of suspect IPV (VERO), suspension for injection (lot T1E87; Expiry Date: 10-Oct-2022) via intramuscular route in the left deltoid for Immunization that was expired with no reported adverse event (expired product administered) (latency: same day). It was asked if the IPOL dose is valid and whether the patient should be reinjected and if so, when and what they should look out for in regards to potential side effects after the patient receives the second IPOL dose. It was reported that Medical Assistant mistook the expiration date on the IPOL MDV that read 10Oct2022 and thought that it meant that it expires in Oct2022 (meaning the last date of the month).  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: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: 72 years old administered fluzone qiv instead of the fluzone hd qiv with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received via Nurse. Agency number: 01337732.  This case involves a 72-year-old female patient to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was administered instead of the fluzone hd qiv with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were given.    On 25-Oct-2022, the 72-year-old patient received suspect fluzone qiv at dose 0.5ml once (lot: UT7701MA, expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for immunization instead of the fluzone hd qiv with no reported adverse event (wrong product administered) at same day latency.  It was reported that "Nurse called stating a patient received the FLUZONE QIV instead of the FLUZONE HD QIV. Caller inquired if the patient needs to be revaccinated or how to proceed with ensuring the patient is fully vaccinated. The nurse who gave it was very upset and when the nurse came back from lunch put her on the phone. Says the patient just walked in and asked for a flu shot because she had been in the office the day before but went home and forgot to get it. Physician didn't order a specific vaccine and discussed with the nurse the patient is age appropriate for Fluzone Quadrivalent, but she says her company is making a hard push that anyone over 64 years old they should give them the Fluzone High Dose Quadrivalent. The company is pushing to give anyone over 64 should be getting the Fluzone High Dose Quadrivalent."  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) 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: 8.0
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK QIV being administered to a patient under the age of 18. (8 year old patient) with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 8 years old male patient who experienced INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] being administered to a patient under the age of 18. (8-year-old patient) with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 23-Oct-2022, the patient received a 0.5ml once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation, lot number and expiry date was unknown) via unknown route in the arm nos for Immunization.  On 23-Oct-2022 the patient developed a non-serious event of flublok qiv being administered to a patient under the age of 18. (8 year old patient) with no reported adverse event (Product administered to patient of inappropriate age )(Latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  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.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 2 patients were administered doses post excursion with no reported adverse event; Temperature excursion at 48.91 Fahrenheit for 838 hours and 59 minutes since June 2022 with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves 2 unknown age and unknown gender patients who were administered doses post temperature excursion at 48.91 Fahrenheit for 838 hours and 59 minutes since June 2022 with no reported adverse event while 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 in Jun-2022, the suspect was exposed to a temperature excursion at 48.91 Fahrenheit for 838 hours and 59 minutes since June 2022 with no reported adverse event (product storage error).  On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength and dose not reported; lot UJ878AA) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the 2 patients were administered doses post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, temperature excursion of unknown cause, reporting not due to human error. Caller reports they are still investigating the cause, either due to malfunction with the refrigerator, data logger malfunction, or not enough circulation with their refrigerator. FLUZONE QIV MDV at a high of 48.91 Fahrenheit out of range for 838 hours and 59 minutes since June 2022, one opened MDV and multiple boxes of unopened product. Caller reports she thinks 2 patients were administered doses post excursion. The FLUZONE QIV MDV that was administered was received on 02SEP2022 and administered the week of 05SEP2022-09SEP2022, at that time the high was 48.91 Fahrenheit out of range for 192 hours.  Action taken was 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: 13.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered flublok qiv to a patient under the age of 18 with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 13 years old female patient to who was administered influenza quadrivalent recombinant vaccine [Flublok QIV] to a patient under the age of 18 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Oct-2022, the patient received 0.5ml dose of suspect influenza quadrivalent recombinant vaccine (lot number and expiry date not reported) via unknown route in the arm nos for Immunization to a patient under the age of 18 with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).  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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expired dose of fluzone qiv,with no reported adverse event; Initial information received  on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], with no reported adverse event.   The patient's past medical history, medical treatment(s), Concomitant medication,  vaccination(s) and family history were not provided.  On 25-OCT-2022 the patient developed a non-serious event of received an expired dose of fluzone qiv (dose, strength, formulation, route, administration site, batch and expiry date was unknown for prophylactic vaccination),with no reported adverse event (expired product administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  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.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired dose of Adacel with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age male patient who received an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On 25-Oct-2022, the patient received 0.5ml, 1 X(once) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation was unknown, lot C5788CA and expiry date: 14-Oct-2022) via intramuscular route in the right deltoid for Immunization.  On 25-OCT-2022 the patient developed a non-serious event of patient received an expired dose of adacel with no reported adverse event (expired product administered, Latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  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 regulatory agency. 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: MNQ
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion of unknown cause, Max/low temperature reached: 32.7F Duration out of labelled range: 1 hour with no reported adverse event; 2 patients were administered menquadfi post excursion with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves 2 patients who received vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] and had temperature excursion of unknown cause, max/low temperature reached: 32.7f duration out of labelled range: 1 hour with no reported adverse event and 2 patients were administered menquadfi post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date there was temperature excursion of unknown cause, max/low temperature reached: 32.7f duration out of labelled range: 1 hour with no reported adverse event (product storage error).  On 05-Oct-2022, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation, strength: unknown) lot U7449AB, expiration date: 23-Sep-2024 via unknown route in unknown administration site as Immunization.  On 05-OCT-2022 the 2 patients were administered menquadfi post excursion with no reported adverse event (poor quality product administered) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.A mini refrigerator was used and it experienced a low excursion.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (temperature excursion of unknown cause, Max/low temperature reached: 32.7F Duration out of labelled range: 1 hour with no reported adverse event, 2 patients were administered menquadfi post excursion with no reported adverse event).  At time of reporting, the outcome was Unknown for all.    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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: Felt palpitations as fast heart beat and some shortness of breath about 10 minutes after receiving the vaccine.  Symptoms lasted about 20 minutes gradually resolving.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: Felt palpitations of fast heart beat with some shortness of breath  about 10 minutes after the vaccination.  Lasted about 20 minutes with gradual resolution.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vertigo
Clinical narrative: Within five hours she was stricken by intense vertigo. I?m still has not lessened and it is now 4 days later. She is missed by school
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness in neck and face; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's Comment:  This case was reported by a patient via interactive digital media. Reporter stated that had second shingles shot and have redness around my neck and part on my face. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site erythema, Injection site warmth, Lymph node pain, Myalgia
Clinical narrative: Redness; Hot to the touch at the area of injection; Hot to the touch; Mild fever; Lymph node aches; Muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site erythema, injection site warmth, touch sensitivity increased, fever, lymph node pain and muscle pain. On an unknown date, the outcome of the injection site erythema, injection site warmth, touch sensitivity increased, fever, lymph node pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, touch sensitivity increased, fever, lymph node pain and muscle pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received dose of Shingles vaccine 5 days ago from the date of reporting, still had redness, hot to the touch at the area of the injection. The patient also experienced mild fever and lymph node and muscle aches continue. The patient asked was this normal. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness; Hot to the touch at the area of injection; Hot to the touch; Mild fever; Lymph node aches; Muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site erythema, injection site warmth, touch sensitivity increased, fever, lymph node pain and muscle pain. On an unknown date, the outcome of the injection site erythema, injection site warmth, touch sensitivity increased, fever, lymph node pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, touch sensitivity increased, fever, lymph node pain and muscle pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received dose of Shingles vaccine 5 days ago from the date of reporting, still had redness, hot to the touch at the area of the injection. The patient also experienced mild fever and lymph node and muscle aches continue. The patient asked was this normal. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: 5 days with headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that It had been 5 days with headache since he/she got of Shingrix. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Burning sensation, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Red rash; Raised rash; Itchy rash; Burning rash; Rash; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID-19 VACCINE BOOSTER) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, Flu vaccine and the 4th dose of COVID-19 VACCINE BOOSTER. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced red rash, raised rash, itchy rash, burning sensation and rash. On an unknown date, the outcome of the red rash, raised rash, itchy rash, burning sensation and rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash, raised rash, itchy rash, burning sensation and rash to be related to Shingles vaccine and Flu vaccine.     Additional Information:  The patient reported that he/she received Shingles vaccine, flu vaccine and his/her 4th booster dose of Covid vaccine. The patient stated that after received Shingles vaccine, flu vaccine and Covid vaccine the patient experienced red, raised, itchy and burning rash. The patient wanted to know that what could he/she take for this. Additional supportive information: Follow-up would not possible as no contact details were available. It was unknown if the reporter considered the red rash, raised rash, itchy rash and burning sensation to be related to COVID-19 VACCINE.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Pyrexia
Clinical narrative: Fever; Upset stomach; Tiredness; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, upset stomach and tiredness. On an unknown date, the outcome of the fever, upset stomach and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the fever, upset stomach and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's Comment:  This case was reported by a patient via interactive digital media. The patient wanted to know that after receiving Shingrix vaccine how long might the fever, upset stomach and tiredness last. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm  as heck as for a good 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR153124   Additional Information: GSK receipt date: 23-OCT- 2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received first dose of Shingrix vaccine experienced sore arm heck for 24 hours. Follow-up would not possible, as no contact, details were available. For tolerance of second dose, refer case US2022AMR153124.; Sender's Comments:  US-GSK-US2022AMR153124:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache, every day, whole day; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2022, the patient received the 1st dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK receipt date: 23-OCT-2022 Reporter's comment:  This case was reported by a consumer via interactive digital media. The patient reported that the he/she got 1st shot of Shingrix last Tuesday and since the he/she had headache every day, whole day. Additional Supportive Information:  Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2019 first dose, late for second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: This case was reported by pharmacist. Pharmacist reported patient was late for the second dose.  No adverse event was reported. No LOT number and expiration date provided. No vaccination date provided only the first dose was administrated. Consented to follow up. Additional supportive information: Till the time of reporting patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Pain in extremity
Clinical narrative: ARM WAS SORE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 06-MAR-2021, the patient experienced arm was sore. Laboratory data (dates unspecified) included: Pain scale 5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: Dizzy; felt sick for 2 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (felt sick for 2 days) and DIZZINESS (Dizzy) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt sick for 2 days) and DIZZINESS (Dizzy). At the time of the report, MALAISE (felt sick for 2 days) had resolved and DIZZINESS (Dizzy) outcome was unknown.            No concomitant medication was reported.    It was reported that, patient in his 40's. The patient felt sick for 2 days and was dizzy after receiving fourth dose of Moderna bivalent vaccine. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-666036 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666036:(MOD22-028046 (father case)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Half dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Half dose) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 12-Mar-2021 and Pfizer on 02-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Immunocompromised.    On 28-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 28-Oct-2022, the patient experienced UNDERDOSE (Half dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Half dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Half dose).    The concomitant medication was not reported by reporter.  On 03-Jun-2022, patient received intramuscular Moderna vaccine injection (lot number 037A22B, expiration date 31-Aug-2022). The dose given on the day of the report by intramuscular injection was a 0.25mL dose. The patient requested this dose because patient was immunocompromised. No reported symptoms. No additional doses, medications, or treatments reported.  The treatment medication was not reported by reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Mobility decreased, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: difficulty lifting up arm-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: numbness and tingling below elbow
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Disorientation, Dizziness, Fall, Loss of consciousness, Skin abrasion
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: After receiving the covid vaccine the patient lost consciousness for a moment causing him to fall out of his chair. Patient was dissoriented for a few minutes following the fainting spell. He did sustain minor abrasions to his face resulting from the fall. He seemed to fully recover after having some gatorade and crackers.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: After receiving the covid vaccine the patient lost consciousness for a moment causing him to fall out of his chair. Patient was dissoriented for a few minutes following the fainting spell. He did sustain minor abrasions to his face resulting from the fall. He seemed to fully recover after having some gatorade and crackers.