chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: employees that were under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no reported adverse event; employees that were under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2022SA446068, 2022SA446195, 2022SA446385, 2022SA447853, 2022SA447822, 2022SA448075, 2022SA447385 and 2022SA448121.  This case involves a 62 years old female patient who was administered Quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] instead of the Fluzone QIV with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2022, the patient received 0.7 ml dose once of suspect Quadrival A-B high dose hv vaccine (lot UT7729CA, exp date: 30-Jun-2022) via intramuscular route in the right deltoid for Immunization at inappropriate age instead of the Fluzone QIV with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency: same day).  Action taken: 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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered the FLUZONE HIGH-DOSE QIV to 9 employees that are under the age of 65 with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA447057(CLUSTER), 2022SA446385(CLUSTER) and 2022SA448075(CLUSTER).  This case involves Adult and unknown gender patient who was administered the fluzone high-dose qiv who was under the age of 65 with no reported adverse event while receiving vaccine 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 (formulation, strength and dose not reported; lot UT7729CA) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the the fluzone high-dose qiv was administered to 9 employees that are under the age of 65 with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  related FLUZONE HD QIV CASE 01340119: related FLUZONE HD QIV CASE 01340226: related FLUZONE HD QIV CASE 01340229: related FLUZONE HD QIV CASE 01340234: related FLUZONE HD QIV CASE 01340240: related FLUZONE HD QIV CASE 01340243: related FLUZONE HD QIV CASE 01340302: related FLUZONE HD QIV CASE 01340314:
Age: 87.0
Sex: F
Vaccine: FLU4, FLUR3
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received 2 different flu vaccines, 1 week apart with no reported adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 87 years old female patient who received 2 different flu vaccines, 1 week apart with no reported adverse event involving vaccines INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].  The patient's past medical history, medical treatment(s),concomitant medication,  vaccination(s) and family history were not provided.   In October 2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 26-Oct-2022, the patient received 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation was unknown, lot QFAA2222 and expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for Immunization.  On 26-Oct-2022 date the patient developed a non-serious event of patient received 2 different flu vaccines, 1 week apart with no reported adverse event (inappropriate schedule of product administration) (latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV 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.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: an extra dose of FLUZONE QUADRIVALENT was accidently administer with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient had an extra dose of fluzone quadrivalent accidently administered with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for Immunisation.  On 03-Oct-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation and strength not reported; lot UT7681LA) via intramuscular route in unknown administration site for prophylactic vaccination.   On 22-Oct-2022 he also received 0.5 mL dose of the same vaccine (formulation and strength not reported; lot UT7695MA) via intramuscular route in unknown administration site for prophylactic vaccination.  On 22-Oct-2022, the patient had an extra dose of fluzone quadrivalent was accidently administered with no reported adverse event (extra dose administered) (latency: same day of dose 2) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, a patient who received 2 doses of FLUZONE QIV syringe. 1st dose received on 03-Oct-2022 and 2nd dose was received on 22-Oct-2022. An extra dose of FLUZONE QUADRIVALENT was accidently administer to a patient. This situation is reported as a medication error due to the patient receiving 2 doses of the vaccine.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: should have given DTaP-IPV-HIB (Pentacel), but instead grabbed QUADRACEL/mistakenly gave a wrong injection with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient and it was reported that patient should have given DTap-Ipv-Hib (Pentacel), but instead grabbed DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (Quadracel) /mistakenly gave a wrong injection 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 (HEPATITIS B VACCINE); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  On 28-Oct-2022, the patient received a dose 1 of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE , at dose of 0.5 ml , once, (lot: U7526AA ; expiry date: not reported) via unknown route in unknown administration site for immunization.  It was reported that patient should have given Dtap-ipv-hib (Pentacel), but instead grabbed quadracel/mistakenly gave a wrong injection with no reported adverse event (wrong product administered) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) 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.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: 11 year old patient was administered DAPTACEL instead of ordered tdap vaccine with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who was administered daptacel instead of ordered tdap vaccine with no reported adverse event, after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included HPV VACCINE (HPV VACCINE)  and meningitis for Immunisation.  On 27-Oct-2022, the patient received a dose number 6  total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE( lot C5883AA and expiration date: 11-May-2023) at a dose of 05ml once via intramuscular route in the left thigh for immunization.  On 27-Oct-2022 (latency: same day), the patient was administered daptacel instead of ordered tdap vaccine with no reported adverse event (wrong product administered).   Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the event   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: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: itching; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-HCP  This case involves a 91 years old female patient who experienced itching after receiving vaccine 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 30-Sep-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.7 ml  total (lot number: not reported; strength, formulation and expiry date unknown) via intramuscular route in left deltoid  for Influenza Immunization.  On 02-OCT-2022 the patient developed  itching (pruritus) 2 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported Caller reported her mother received FLUZONE HIGH-DOSE QUADRIVALENT on 30SEP2022 and started itching on 2OCT2022 and has been ever since. She was taken to the Doctor on 4OCT2022 and has been prescribed Benadryl, Hydroxyzine, Prednisone and had an injection of Solumedrol that relieved symptoms for about 2 days. No hives, blisters, bumps observed.   Action taken  was not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Pruritus, HYDROXYZINE (HYDROXYZINE) for Pruritus, PREDNISONE (PREDNISONE) for Pruritus and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Pruritus.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event itching.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental exposure to product, No adverse event, Syringe issue
Clinical narrative: started to administer the product but fluid leaked onto her gloves and skin with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11-year-old male patient to whom when started to administer the product INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] but fluid leaked onto her gloves and skin with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Oct-2022, to the patient when started to administer suspect INFLUENZA QUADRIVAL A-B VACCINE at dose of 0.25 ml total (strength: standard; formulation: unknown) (lot number: UJ943AA and expiry date: 30-Jun-2023) via intramuscular route in the deltoid nos for Immunization, but fluid leaked onto her gloves and skin with no reported adverse event (accidental exposure to product) (latency: same day).  It was reported, that during the administration of the vaccine and got a lot of spill. Pharmacist was not sure how much of the vaccine the patient got. She would like to know do they need to re-dose the patient or leave it as is? Pharmacist reported that FLUZONE QUADRIVALENT PREFILLED SYRINGE, was used and after removing the air, the caller started to administer the product but there was significant leakage on the sides and bottom of the syringe.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was 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: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered expired TENIVAC  with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 85 years old female patient who was administered expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that on 26-Oct-2022 , the patient was administered expired dose of 0.5 ml once of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, ( lot : U6852AA ; expiry date: 07-Oct-2022) with no reported adverse event (expired product administered) , given via intramuscular route in right deltoid for immunization  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: 10.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: was mistakenly administered an ipol vaccination today, that had expired on 10oct2022 with no reported adverse event; Initial information was received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 10 years old male patient who was mistakenly administered an ipv (VERO) [Ipol] vaccination today, that had expired on 10oct2022 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 for Prophylactic vaccination.  On 28-Oct-2022, the patient received a dose 2 of suspect ipv (VERO) standard suspension for injection at dose of 0.5 ml once (lot T1E871M, expiry date - 10-Oct-2022) via intramuscular route in the right deltoid for Immunization and was mistakenly administered an ipv (VERO) vaccination today, that had expired on 10oct2022 with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired TENIVAC was given to a patient with no reported Adverse event; Initial information was received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 65 years old female patient who was administered an expired diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] 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 for Prophylactic vaccination.  On 28-Oct-2022, the patient received a Booster dose of suspect standard diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT suspension for injection at a dose of 0.5 ml once (lot C5779AA, expiry date - 10-Feb-2022) via intramuscular route in the left deltoid for Immunization and was administered an expired diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: experience intense itching; urticaria; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 82 years old male patient who experienced intense itching and urticaria ,after  receiving vaccine 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.At the time of the event, the patient had ongoing with multiple health issues of late, including heart issues.Concomitant medications included TRAMADOL (TRAMADOL) for Neuropathy and a beta-blocker for cardiac arrythmia.  On 01-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On 03-OCT-2022 (latency: 2 days), the patient developed a non-serious events of " intense itching" (pruritus) and " urticaria" following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported"Within 2 days he began to experience intense itching, which continues to this date. He reports that at first he thought it might be related to 2 new medications that he had recently started taking; Tramadol for neuropathy and a beta-blocker for cardiac arrythmia. He tried discontinuing both of them, but the urticaria continued. He states that he tried taking Benadryl, but that did nothing for him. Now he's taking Zyrtec, but so far that's done nothing either"  Action taken:not applicable.  Corrective treatment:DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ) for Urticaria and Pruritus.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event experience intense itching and was Not Recovered / Not Resolved for the event urticaria.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patients received a FLUZONE QIV HD dose earlier in October, and inadvertently received another during their visit today. with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an 86-year-old female patient who had received a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] dose earlier in October, and inadvertently received another during their visit today. with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation: unknown) (lot number: UJ926AD and expiry date:  30-Jun-2023) via intramuscular route in unknown administration site. On 28-Oct-2022 she also received 0.7ml dose of the same vaccine lot UJ926AD via intramuscular route in the right deltoid for Immunization.  On 28-Oct-2022, a non-serious event occurred, patient received a fluzone qiv hd dose earlier in October, and inadvertently received another during their visit today. with no reported adverse event (extra dose administered) (latency: 21 days).  It was reported, They are asking what needs to be done in the case of an extra dose such as this?.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was 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: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: A pregnant patient was administered Fluzone QIV with no reported AE; Initial information received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult female patient who was pregnant  and who got INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] with no reported adverse event.   The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies.   On 27-Oct-2022, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot UJ8788A expiry date of 30-jun-2023 via unknown route in the left deltoid for Immunization.  On 27-OCT-2022 the patient who was pregnant  was administered fluzone qiv with no reported ae (maternal exposure timing unspecified) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event a pregnant patient was administered fluzone qiv with no reported ae.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 1.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: of ACTHIB that was expired by two days with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 14 months old female patient who was given act-hib that was expired by two days with no reported adverse event , after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Oct-2022, the patient received a  once dose of suspect HIB (PRP/T) VACCINE( lot UJ594AAA and expiration date: 28-Oct-2022) at a dose of 0.5ml at an unknown route  in the left thigh. as prophylactic vaccination.  On 28-Oct-2022 (latency: same day) ,the patient was administered acthib that was expired by two days with no reported adverse event (expired product administered).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   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: 15.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: No reaction. Inappropriate administration. Patient received bivalent booster instead of 1st dose in primary series
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram, Hypothyroidism, Laboratory test, Mobility decreased
Clinical narrative: After 2nd dose, I developed a severe weakness literally overnight.  Had to stop painting my house as I couldn't even climb the ladder. My B12 and Thyroid levels fell to non existance.  My physical weakness has not declined.  I take a B12 shot once a month and after 2 years, my thyroid level has finally reached in the normal range.   I have seen Dr. for this issue.   My second issue is at 70 years old I started bleeding from the vagina.   I have gone through a D&C late 2021 but did not solve the problem.   Dr. is going to now due a hysterectomy as no real reason for my bleeding can be determined other than The Covid vaccine and it is not natural for a women over 70 to bleed.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Uterine dilation and curettage, Vaginal haemorrhage, Vitamin B12 decreased
Clinical narrative: After 2nd dose, I developed a severe weakness literally overnight.  Had to stop painting my house as I couldn't even climb the ladder. My B12 and Thyroid levels fell to non existance.  My physical weakness has not declined.  I take a B12 shot once a month and after 2 years, my thyroid level has finally reached in the normal range.   I have seen Dr. for this issue.   My second issue is at 70 years old I started bleeding from the vagina.   I have gone through a D&C late 2021 but did not solve the problem.   Dr. is going to now due a hysterectomy as no real reason for my bleeding can be determined other than The Covid vaccine and it is not natural for a women over 70 to bleed.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Administered monovalent vaccine instead of bivalent.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine given instead of bivalent.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Appendicectomy, Appendicitis, Computerised tomogram abdomen abnormal
Clinical narrative: Acute appendicitis day after injection
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Erythema, Pain, Pruritus, Skin discolouration
Clinical narrative: Red bruise painful to touch bigger than plum with a white halo around that increased in size by Sunday Nov. 6 pain was moving up towards my shoulder the bruise started to itch as it got bigger.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling, Tenderness
Clinical narrative: Red bruise painful to touch bigger than plum with a white halo around that increased in size by Sunday Nov. 6 pain was moving up towards my shoulder the bruise started to itch as it got bigger.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Hemiparesis, Pain in extremity
Clinical narrative: patient described transient left sided weakness, followed by left sided pains in the leg and foot.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: The patient is 11 years old and was given a Pfizer Bivalent vaccine intended for those 12 and older.  The patient's mother was informd.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I came down with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-OCT-2022. Reporter's comment: This case was reported by the reporter via interactive digital media. The reporter stated that he/she had taken the first dose of Shingrix but before he/she could take the 2nd dose, he/she had come down with shingles. The reporter had also asked if, he/she should wait before taking the second dose. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st shot Sep2021, 2nd 31oct2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2021).   On 30th October 2022, the patient received the 2nd dose of Shingrix. On 30th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got busy and did not receive second dose of Shingrix till today and received on 30th October 2022 (on the day of reporting). The patient assumed he/she would still benefit from it despite being six months later than recommended on second dose. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. Follow-up would not possible as no contact details were available.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 1-MAR-2022. 2nd dose was today 1-NOV; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old male patient who received HAB (Twinrix) (batch number 2ke55, expiry date 22nd September 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 1st March 2022).   On 1st November 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 1st November 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's comment: The pharmacist reported that the patient received second dose of Twinrix today (on the day of reporting). The expiration date was from salesforce. The reporter did not consent to follow up. Additional Supportive Information: The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: interval between the 1st and 2nd dose, was over 1 year; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The pharmacist reported that the interval between the first and second dose of Shingrix, was over one year. The pharmacist had limited information on the patient and vaccine details. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: 2nd dose of Moderna vaccine not received for greater than 36 days/never got dose 2; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (2nd dose of Moderna vaccine not received for greater than 36 days/never got dose 2) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (2nd dose of Moderna vaccine not received for greater than 36 days/never got dose 2) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (2nd dose of Moderna vaccine not received for greater than 36 days/never got dose 2) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (2nd dose of Moderna vaccine not received for greater than 36 days/never got dose 2).    Concomitant medications were not reported.   Treatment medications were not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Illness, Myalgia
Clinical narrative: Sick as a dog 14 Hours after the first monovalent booster; Body aches 14 Hours after the first monovalent booster; Fatigue 14 Hours after the first monovalent booster; Fever 101.4F 14 Hours after the first monovalent booster; Chills 14 Hours after the first monovalent booster; Nausea 14 Hours after the first monovalent booster; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick as a dog 14 Hours after the first monovalent booster), MYALGIA (Body aches 14 Hours after the first monovalent booster), FATIGUE (Fatigue 14 Hours after the first monovalent booster), PYREXIA (Fever 101.4F 14 Hours after the first monovalent booster) and CHILLS (Chills 14 Hours after the first monovalent booster) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced ILLNESS (Sick as a dog 14 Hours after the first monovalent booster), MYALGIA (Body aches 14 Hours after the first monovalent booster), FATIGUE (Fatigue 14 Hours after the first monovalent booster), PYREXIA (Fever 101.4F 14 Hours after the first monovalent booster), CHILLS (Chills 14 Hours after the first monovalent booster) and NAUSEA (Nausea 14 Hours after the first monovalent booster). On 14-Nov-2021, ILLNESS (Sick as a dog 14 Hours after the first monovalent booster), MYALGIA (Body aches 14 Hours after the first monovalent booster), FATIGUE (Fatigue 14 Hours after the first monovalent booster), PYREXIA (Fever 101.4F 14 Hours after the first monovalent booster), CHILLS (Chills 14 Hours after the first monovalent booster) and NAUSEA (Nausea 14 Hours after the first monovalent booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, Body temperature: 101.4 F.         No concomitant medications were reported. After shot, patient had events for 30 hours. No treatment information was provided.   This case was linked to MOD-2022-669096, MOD-2022-669098 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Sick as a dog 14 Hours after the first monovalent booster; Body aches 14 Hours after the first monovalent booster; Fatigue 14 Hours after the first monovalent booster; Fever 101.4F 14 Hours after the first monovalent booster; Chills 14 Hours after the first monovalent booster; Nausea 14 Hours after the first monovalent booster; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick as a dog 14 Hours after the first monovalent booster), MYALGIA (Body aches 14 Hours after the first monovalent booster), FATIGUE (Fatigue 14 Hours after the first monovalent booster), PYREXIA (Fever 101.4F 14 Hours after the first monovalent booster) and CHILLS (Chills 14 Hours after the first monovalent booster) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced ILLNESS (Sick as a dog 14 Hours after the first monovalent booster), MYALGIA (Body aches 14 Hours after the first monovalent booster), FATIGUE (Fatigue 14 Hours after the first monovalent booster), PYREXIA (Fever 101.4F 14 Hours after the first monovalent booster), CHILLS (Chills 14 Hours after the first monovalent booster) and NAUSEA (Nausea 14 Hours after the first monovalent booster). On 14-Nov-2021, ILLNESS (Sick as a dog 14 Hours after the first monovalent booster), MYALGIA (Body aches 14 Hours after the first monovalent booster), FATIGUE (Fatigue 14 Hours after the first monovalent booster), PYREXIA (Fever 101.4F 14 Hours after the first monovalent booster), CHILLS (Chills 14 Hours after the first monovalent booster) and NAUSEA (Nausea 14 Hours after the first monovalent booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, Body temperature: 101.4 F.         No concomitant medications were reported. After shot, patient had events for 30 hours. No treatment information was provided.   This case was linked to MOD-2022-669096, MOD-2022-669098 (Patient Link).
Age: 18.0
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: experienced an allergic reaction after receiving the bivalent COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (experienced an allergic reaction after receiving the bivalent COVID-19 vaccine) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (experienced an allergic reaction after receiving the bivalent COVID-19 vaccine). At the time of the report, IMMUNISATION REACTION (experienced an allergic reaction after receiving the bivalent COVID-19 vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient was over 18 years old.  Reporter wanted to find out about Covid-19 vaccine as the patient experienced Allergic reaction to after receiving the bivalent COVID-19 vaccine.  Patient received an infusion 9 day prior.  No treatment information was reported.   Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discolouration
Clinical narrative: After receiving vaccination, a large black and blue mark (about 4 - 5 inches in diameter) appeared 6 inches below the injection site; Initial information received on 30-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 79 years old male patient who reported after receiving vaccination, a large black and blue mark (about 4 - 5 inches in diameter) appeared 6 inches below the injection site after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Stent insertion NOS. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Type 2 diabetes mellitus, Hypertension and High cholesterol.   On 27-Oct-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, lot number and expiry date: unknown) via intramuscular route for Routine seasonal vaccination.  On 30-Oct-2022 the patient developed a non-serious event of after receiving vaccination, a large black and blue mark (about 4 - 5 inches in diameter) appeared 6 inches below the injection site (skin discolouration) (latency: 3 days) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Recovering