chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE prefilled syringes was administered to  patients after excursion with no adverse event; Initial information received on 17-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to US-SA-2024SA376929 (master case).  This case involves a 4 years old female patient for whom Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] prefilled syringes was administered after excursion 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 Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection prefilled syringes (lot U8523BA, expiry date- 30-JUN-2025) via unknown route in unknown administration site for Influenza immunisation, after excursion with no adverse event (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA376929:master case
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: B precursor type acute leukaemia, Brief resolved unexplained event, Cyanosis, Electroencephalogram, Epilepsy
Clinical narrative: Patient stopped breathing she turned purple was smacking her lips was spaced out and her oxygen levels were high she started to foam from the mouth, Stiff.  minutes
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Feeling abnormal, Foaming at mouth, Gastrooesophageal reflux disease, Magnetic resonance imaging head abnormal, Musculoskeletal stiffness
Clinical narrative: Patient stopped breathing she turned purple was smacking her lips was spaced out and her oxygen levels were high she started to foam from the mouth, Stiff.  minutes
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Respiratory arrest, Tardive dyskinesia
Clinical narrative: Patient stopped breathing she turned purple was smacking her lips was spaced out and her oxygen levels were high she started to foam from the mouth, Stiff.  minutes
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong technique in product usage process
Clinical narrative: Vaccine previously activated administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in product usage process in a 61-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 235D2) for prophylaxis.   Previously administered products included Tetanus toxoid (received another Tetanus Toxoid vaccine back in 1974 unknown brand), Diphtheria toxoid (received Reduced Diphtheria Toxoid vaccine back in 1974 unknown brand) and Acellular pertussis (received Acellular Pertussis vaccine back in 1974 unknown brand).   On 25-NOV-2024, the patient received Boostrix. On 25-NOV-2024, an unknown time after receiving Boostrix, the patient experienced wrong technique in product usage process (Verbatim: Vaccine previously activated administered). The outcome of the wrong technique in product usage process 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: 25-NOV-2024 The nurse explained that since a Boostrix prefilled syringe that was activated on 22nd November 2024 with the needle attached, it was put back in the fridge and used today (on the day of reporting) to administer the dose to a patient, which led to wrong technique in product usage process.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered a dose of Kinrix to the patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 20-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 13-SEP-2024, the patient received the 2nd dose of Kinrix. On 13-SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered a dose of Kinrix to the patient.). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-DEC-2024 The health care professional reported that a patient was due to receive polio and DTaP vaccines. The medical assistant administered a dose of Knirix to the patient, which led to inappropriate age at vaccine administration. The Kinrix dose made the second polio and DTaP doses for this patient. The vaccine administration facility was the same as primary reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: states that her daughter received a dose of KINRIX when she was 3 years old; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: states that her daughter received a dose of KINRIX when she was 3 years old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-DEC-2024 The reporter reported that a patient received a dose of Kinrix vaccine when she was 3 years old, the vaccine was only approved for children aged for 4 to 6 years, which led to inappropriate age at vaccine administration.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Kinrix doses at 4 months of age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Concomitant products included Pneumococcal vaccine, Rotavirus vaccine, Pediarix and Polio vaccine inact (Ipv).   On 10-DEC-2024, the patient received Kinrix. On 10-DEC-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered Kinrix doses at 4 months of age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-DEC-2024 The health care professional reported that a patient inadvertently administered Kinrix doses at 4 months of age, which led to inappropriate age at vaccine administration. Prior to this dose, the patients had received one prior DTaP and IPV (Pediarix, administered on 08-OCT-2024).   The reporter also mentioned that the patients also received oral rotavirus vaccine and pneumonia 15 vaccine on 10-DEC-2024 as well. The administration facility was the same as primary reporter. This case is linked with US2024155526, reported by same reporter.; Sender's Comments:  US-GSK-US2024155526:same reporter /another patient
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unapproved Age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Concomitant products included Pneumococcal vaccine, Rotavirus vaccine, Pediarix and Polio vaccine inact (Ipv).   On 10-DEC-2024, the patient received Kinrix. On 10-DEC-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved Age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-DEC-2024 The health care professional reported that a patient inadvertently administered Kinrix doses at 4 months of age, which led to inappropriate age at vaccine administration. Prior to this dose, the patients had received one prior DTaP and IPV (Pediarix, administered on 08-OCT-2024).   The reporter also mentioned that the patients also received oral rotavirus vaccine and pneumonia 15 vaccine on 10-DEC-2024 as well. The administration facility was the same as primary reporter. This case is linked with US2024155523, reported by same reporter.; Sender's Comments:  US-GSK-US2024155523:same reporter /another patient
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Joint swelling, Juvenile idiopathic arthritis
Clinical narrative: Joint pain and swelling which was diagnosed as juvenile idiopathic arthritis; Joint pain; swelling; Initial information received on 17-Dec-2024 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 33 months old female patient who had joint pain and swelling which was diagnosed as juvenile idiopathic arthritis after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] And Covid-19 Vaccine.  The patient's past medical history included Eczema. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2024, the patient received a dose of suspect  Influenza Quadrival A-B Multidose Vaccine Preserved Suspension for injection in the left arm  for prophylactic vaccination and COVID-19 VACCINE in the arm NOS for COVID-immunization (unknown strength, dosage, expiry date, formulation, batch number and route).  On 13-Oct-2024 the patient developed joint pain (arthralgia) and swelling (joint swelling) which was diagnosed as juvenile idiopathic arthritis (juvenile idiopathic arthritis) (latency-12 days) following the administration of  Influenza Quadrival A-B Multidose Vaccine Preserved and COVID-19 Vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovering / Resolving for all the events.  Seriousness criteria: The  event (juvenile idiopathic arthritis) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 25-Dec-2024: This case involves a 33 months old female patient who had joint pain and swelling which was diagnosed as juvenile idiopathic arthritis, joint pain and swelling after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] And Covid-19 Vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 0.75
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: ipol (opened) was administered to patient post-temperature excursion 10.3 cel for 19 minutes with no reported adverse event; Initial information received on 17-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2024SA378165.  This case involves a 10 months old female patient who was administered ipv (vero) [Ipol] (opened) post-temperature excursion 10.3 degree Celsius for 19 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Dec-2024, the patient received 0.5 mL dose of suspect ipv (vero) (Suspension for injection) (frequency: once) (strength: standard) (lot W1C831M and expiry date: 21-Nov-2025) via intramuscular route in unknown administration site for immunization, post-temperature excursion 10.3 degree Celsius for 19 minutes with no reported adverse event (poor quality product administered) (latency: same day).   Reportedly, The temperature excursion had negative disposition and product was used. Reporter said that they had a temperature excursion and that before they knew they had one, they had already administered the vaccine to two other patients. Previous Excursion was reported as none. Human error was reported as unknown. The extended stability data didn't cover the excursion.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA378165:02345290 for patient 2
Age: 11.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: ipol (opened) was administered to two patients post-temperature excursion, 10.3°C for 19 minutes with no reported adverse event; Initial information received on 17-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient received (opened) IPV (VERO) [IPOL] was administered to two patients post-temperature excursion, 10.3°c for 19 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Dec-2024, the patient received a dose of suspect 0.5 ml (1X-once) IPV (VERO) (opened) (Standard) (lot W1C831M, expiry date: 21-Nov-2025) via intramuscular route in unknown administration site for Immunization was administered to two patients post-temperature excursion, 10.3°c for 19 minutes with no reported adverse event (poor quality product administered) (latency unknown).  Reportedly, Temperature excursion: negative disposition and product used. Medical assistant said that they had a temperature excursion and that before they knew they had one, they had already administered the vaccine to two other patients. Medical assistant wanted to know if they should repeat the vaccination.   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: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: break once they were pushing the plunger to inject; that with pushing a snap was heard and then the vaccine was see running down the arm with no reported adverse event; break once they were pushing the plunger to inject; that with pushing a snap was heard and then the vaccine was see running down the arm with no reported adverse event; Initial information received on 17-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66 years old male patient who received influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] during break once they were pushing the plunger to inject; that with pushing a snap was heard and then the vaccine was see running down the arm with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect influenza usp trival a-b high dose subvirion vaccine (Suspension for injection in pre-filled syringe) (lot U8532CA and expiry date: 30-Jun-2025) via unknown route in unknown administration site for prophylactic vaccination during break once they were pushing the plunger to inject; that with pushing a snap was heard and then the vaccine was see running down the arm with no reported adverse event (accidental exposure to product) and (exposure via skin contact) (latency: same day).   Reportedly, A Clinic reporting having 1-FLUZONE HD syringe to break in half described as the neck of the syringe broke off at the needle connection. The consumer received another dose of the vaccine; that the clinic is seeking credit on their account for the broken syringe.   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: FLU3
Symptoms: Diplopia
Clinical narrative: double vision; Initial information received on 17-Dec-2024 regarding an unsolicited valid  non-serious case received from a consumer/Non-Healthcare Professional.  This case linked to US-SA-2024SA378613 (cluster case).  This case involves a 65 years old female patient who experienced double vision after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Dec-2024, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe (lot number, strength and expiry date not reported) via unknown route in unknown administration site for influenza. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On unknown date in DEC-2024 the patient developed double vision (diplopia) (few days latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (double vision).  At time of reporting, the outcome was Unknown for the event double vision.; Sender's Comments:  US-SA-2024SA378613:
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: they have a dose of ACT HIB that was reconstituted using sterile water, not the diluent that was provided in the factory box, with no reported adverse event; Initial information received on 17-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 months old male patient who received HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted using sterile water, not the diluent that was provided in the factory box, with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 09-Dec-2024, the patient received a dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization that was reconstituted using sterile water, not the diluent that was provided in the factory box, with no reported adverse event (product preparation error) (Latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Caller verified that the ACTHIB diluted with sterile water was given to a patient. Caller suggests including the recommendations in case of administration of product diluted in an alternate diluent in the prescribing information or making it available online since they could not find anything about it Caller stated that they are not comfortable with giving the patient's date of birth. They also said that they do not have complete information yet and that they will be doing a VAERS report later on as well.   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: PNC20
Symptoms: Occipital neuralgia
Clinical narrative: Occipital neuralgia for 3 days left side of head
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Develop shingles in January 2022 six months after second dose
Age: 66.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I was fine until I got Vovid on 12/19/2024. DX at medical on 12/20/2024 during sick visit. Given Paxlovid . Completed  on 12/24/2024.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Medical device site infection
Clinical narrative: Feeding tube infection
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: yesterday that a patient received only the DTap-IPV liquid component of the PENTACEL, and the ACTHIB lyophilized powder was not reconstituted with no reported adverse event; Initial information received on 17-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received only the dtap-ipv liquid component of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)], and the acthib lyophilized powder was not reconstituted with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Dec-2024, the patient received unknown dose of only the dtap-ipv liquid component of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] (Suspension for injection) via unknown route in unknown administration site for Immunization and the acthib lyophilized powder was not reconstituted with no reported adverse event (single component of a two-component product administered) (latency: same day) (lot number and expiry date not reported).  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  Reportedly, reporter asked for recommendations on how soon they can administer the ACTHIB component. Reporter did not have the necessary information regarding the patient and the PENTACEL administration.   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: 1.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product storage error
Clinical narrative: daptacel was administered to 1 patient after excursion with no reported adverse event; Initial information received on 17-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient was administered Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] after excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (unknown strength, dosage and route) (lot-3CA11C1, expiry: 31-Dec-2025) via unknown administration site for prophylactic vaccination after excursion with no reported adverse event (poor quality product administered) (unknown latency).  Reportedly, Temperature excursion: negative disposition and product used.   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: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Fatigue, Female reproductive neoplasm, Laboratory test, Peripheral swelling
Clinical narrative: fatigue, swelling to arms and legs, eventually severe blood clots discovered ....  then cancer, aggressive cancer.... then death after 3.5 year battle....
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis with thrombocytopenia syndrome
Clinical narrative: fatigue, swelling to arms and legs, eventually severe blood clots discovered ....  then cancer, aggressive cancer.... then death after 3.5 year battle....
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash near the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) (batch number GA99K) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 11-AUG-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: rash near the injection site). Rechallenge with Shingrix was positive. The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-NOV-2024 Pharmacist stated female patient received Shingrix and got a rash near the injection site from both that had not resolved. Later in the call the patient could be heard in the background of the pharmacy stating the rash from the first dose did improved, but did not completely resolved. Pharmacist then stated the first dose was given about two months before the second dose, but both rashes are still unresolved. The pharmacist and patient both mentioned an FDA study, which the patient found online, that showed if a rash occurred there were two types, one where rash occurred and resolved in 5 a days, and one where the rash was not immediate, but ultimately within 10 to 15 days, and then it spread to other parts of body. The study indicated for that group that if you got that type of rash, they said it was vaccine failure. Pharmacist stated the patient's first dose was on 8/6 and the second was on 11/8. The Lot of the second dose was GA99K. For tolerance of 1st dose refer case US2024148202.; Sender's Comments:  US-GSK-US2024148202:SAME PATIENT
Sex: U
Vaccine: TDAP, TDAP
Symptoms: Anaphylactic reaction, Extra dose administered, Hypersensitivity, Injury
Clinical narrative: Deadly allergic reaction, Anaphylaxis; injury; Adacel and BOOSTRIX was administered on same day; Initial information received on 19-Dec-2024 regarding an unsolicited valid  serious case received from a patient.  This case involves an unknown age/gender patient who experienced deadly allergic reaction, anaphylaxis, injury and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [BOOSTRIX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Jun-2021, the patient received a dose of suspect BOOSTRIX not produced by Sanofi Pasteur (formulation: unknown) and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection both were administered on same day (extra dose adminsterered) (latency same day)  [dose, strength, lot, administration site and expiry: unknown] for prophylactic vaccination.  On 14-JUN-2021 the patient developed a serious deadly allergic reaction, anaphylaxis (anaphylactic reaction) (latency 3 days).  This event was assessed as medically significant.  On 14-JUN-2021 the patient developed a non-serious injury (latency 3 days).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (Deadly allergic reaction, Anaphylaxis and injury).  At time of reporting, the outcome was Unknown for the events (Deadly allergic reaction, Anaphylaxis and injury).  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: Sanofi company comment dated: 25-Dec-2024:- This case involves an unknown age/gender patient who experienced deadly allergic reaction, anaphylaxis, injury and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [BOOSTRIX]. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any family history patient past medical history and concurrent condition precludes comprehensive case assessment.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix first dose in the Dtap and IPV series; Kinrix administered under 4 years old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number T34J, expiry date 25-JAN-2025) for prophylaxis.   On 26-NOV-2024, the patient received the 1st dose of Kinrix. On 26-NOV-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix first dose in the Dtap and IPV series) and inappropriate age at vaccine administration (Verbatim: Kinrix administered under 4 years old). The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-NOV-2024 The licensed practical nurse reported that 4 months patient received Kinrix instead of a separated vaccine of Dtap and IPV and this was first Dtap and IPV dose, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: FLU3
Symptoms: Diplopia
Clinical narrative: patient having eye problems/double vision after receiving the fluzone hd; Initial information received on 17-Dec-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case linked to US-SA-2024SA379368 (cluster case).  This case involves an unknown age and unknown gender patient who experienced eye problems/double vision after receiving the fluzone hd while receiving vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (strength: not reported) (lot number, expiry date: not reported) via unknown route in unknown administration site for Influenza (Influenza immunization).  On an unknown date the patient developed eye problems/double vision after receiving the fluzone hd (diplopia) (unknown latency) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  No lab data reported.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.; Sender's Comments:  US-SA-2024SA379368:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Rhabdomyolysis
Clinical narrative: Rhabdomyolysis while hiking. Increased CK Increased LFT. Tx: Rest, hydration. Resolved.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Doctor ordered Flu vaccine. Nurse gave Vaxelis. She pulled the wrong vaccine from the stock
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received same vaccine twice by mistake: 12/29/2023 and 12/20/2024
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had gotten the Arexvy vaccine already on 10/11/23. Patient stated she had never received the vaccine before and requested the shot again.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Antinuclear antibody positive, Blood thyroid stimulating hormone normal, Fatigue, Headache
Clinical narrative: Between 17 & 19 hours after the vaccination, my entire left side under my armpit swelled to the point where it hurt when my arm touched it. I emailed my doctor with an FYI message, I got no reply. on day 2 following the vaccination, I developed headache, sore, swelled throat, sinus issues and fatigue. 7 months later, early August, my thyroid TSH was 9.46 and I found a bald patch on my scalp. My GP ran ANA, came back positive.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Oedema peripheral, Oropharyngeal pain, Pharyngeal swelling, SARS-CoV-2 test negative
Clinical narrative: Between 17 & 19 hours after the vaccination, my entire left side under my armpit swelled to the point where it hurt when my arm touched it. I emailed my doctor with an FYI message, I got no reply. on day 2 following the vaccination, I developed headache, sore, swelled throat, sinus issues and fatigue. 7 months later, early August, my thyroid TSH was 9.46 and I found a bald patch on my scalp. My GP ran ANA, came back positive.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder, Tenderness
Clinical narrative: Between 17 & 19 hours after the vaccination, my entire left side under my armpit swelled to the point where it hurt when my arm touched it. I emailed my doctor with an FYI message, I got no reply. on day 2 following the vaccination, I developed headache, sore, swelled throat, sinus issues and fatigue. 7 months later, early August, my thyroid TSH was 9.46 and I found a bald patch on my scalp. My GP ran ANA, came back positive.
Age: 0.58
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Varicella vaccine that was supposed to give at the age of 12 months, was given at the age of 7 months by error.
Age: 62.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pruritus
Clinical narrative: itching around injection site
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was scheduled to receive Hepatitis B Vaccine Booster. The patient was given Hepatitis A Vaccine in error.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Rheumatoid factor
Clinical narrative: Developed joint swelling and pain.  Began in neck, shoulders and feet.  Migrated to hands within a few weeks.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan abnormal
Clinical narrative: A few hours after getting the vaccine the pt developed a 3 inch large lump on her left groin in her lymph gland. She was taken to urgent care. She was sent directly to the ER Hospital. She was given an ultrsound. She was diagnosed with swollen lymph node and released to follow up with PCP.  PCP thinks she may need to have it surgically removed but will see her again before referring her to a surgeon. Family is concerned about the pt having to go under anesthesia for surgery because of her history of seizures and medical issues.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Vaccination site pain
Clinical narrative: On 12/20/2024 it was reported that, beginning 1-2 days post vaccination patient began to  c/o tenderness at vaccine sites and weakness of both upper extremities, continuing to this day.  The weakness interfered with his ability to participate in his  high school wrestling program.  Patient was evaluated by a physician at an Urgent Care Walk In Center and prescribed Naproxen 500mg daily x 5 days.  He felt well enough to return to wrestling today (12/26/24)
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Feeling abnormal, Loss of consciousness, Mental impairment
Clinical narrative: 1:00am shivers and chills for hours.   Felt awful upon arising.  Passed out and hit floor with head left side.  Didn?t feel normal mentally for at least seven days
Age: 1.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Child had no adverse events related to vaccine. They were given Abrysvo by mistake instead of Beyfortus.
Age: 22.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: The patient said the first shot (Arexvy) felt fine, but the second shot (Flu) hurt immediately.  He said his arm was sore for a couple days, and he used ice at the injection site to help the pain.  He said it did get better after 2 or 3 days, but then maybe a week later he started to experience stiffness in his left shoulder and pain with movement which limits his range of motion.  He said he is an avid golfer and hopes this will not affect his swing.  He made an appointment with an orthopedist, but he won't be seen until March 2025.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: patient states they have arm pain and soreness that is still lasting, it is painful when laying down on that arm and when they move their arm
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: N/a
Age: 57.0
Sex: F
Vaccine: HEP, TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Peripheral swelling, X-ray limb
Clinical narrative: Left arm swollen, red and tender following vaccination. Difficulty raising arm due to pain. Ice/heat, Motrin and Percocet for treatment.
Age: 14.0
Sex: M
Vaccine: FLU3, MMRV, MNQ, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: none noted or reported
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: An adult patient was given the Moderna vaccine for a 6?11-year-old.  Patient was notified and asked to return for the proper dose per CDC.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient previously received RSV Arexvy vaccine on 10/30/2023 and received second dose on 11/12/2024.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Pain, Pyrexia
Clinical narrative: Fever, severe chills, loss of appetite, aches, pain.
Age: 0.67
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given before age 12 months. Not valid. patient tolerated, no symptoms
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PT should have received Tdap for his age.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: ENDORSES redness at the injection site ENDORSES hot to touch at injection site ENDORSES swelling at the injection site ENDORSES fatigue
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Asthma, Chills, Condition aggravated, Decreased appetite
Clinical narrative: Symptoms: Afternoon 10/21: Chills, uncontrollable shaking; nausea; asthma exacerbation/shortness of breath (PFR dropped from 290 before flu shot to 240 on 10/22 a.m.). Morning 10/22: fever 102.2 (highest). Fatigue, weakness, anorexia. Didn't eat for > 1 day. Felt unstable, maybe light-headed when I got up to go to the bathroom--used a walker; Afternoon: diarrhea while sleeping; After about 2 days arms and legs itched incessantly (no rash); then, itchy red rash patch behind left knee; some itchy red spots around right ankle. Treatments: Acetaminophen TID for 3 days. Albuterol, 2 puffs TID or BID for 10 days; Flovent 110, 4 puffs BID for 2 days; 3 puffs BID for 2 days; 2 puffs for 2.5 days. (Ran out of Flovent; then used Arnuity Ellipta again.) Peak flow normal after 5 days, but I still had chest congestion. Rash: applied cortisone cream; rash lasted about 1.5 days. I was in bed for >2 days. I didn't feel fully recovered until about 6 days. I have never had any reaction except local to any immunization I have received over decades.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Feeling abnormal, Nausea
Clinical narrative: Symptoms: Afternoon 10/21: Chills, uncontrollable shaking; nausea; asthma exacerbation/shortness of breath (PFR dropped from 290 before flu shot to 240 on 10/22 a.m.). Morning 10/22: fever 102.2 (highest). Fatigue, weakness, anorexia. Didn't eat for > 1 day. Felt unstable, maybe light-headed when I got up to go to the bathroom--used a walker; Afternoon: diarrhea while sleeping; After about 2 days arms and legs itched incessantly (no rash); then, itchy red rash patch behind left knee; some itchy red spots around right ankle. Treatments: Acetaminophen TID for 3 days. Albuterol, 2 puffs TID or BID for 10 days; Flovent 110, 4 puffs BID for 2 days; 3 puffs BID for 2 days; 2 puffs for 2.5 days. (Ran out of Flovent; then used Arnuity Ellipta again.) Peak flow normal after 5 days, but I still had chest congestion. Rash: applied cortisone cream; rash lasted about 1.5 days. I was in bed for >2 days. I didn't feel fully recovered until about 6 days. I have never had any reaction except local to any immunization I have received over decades.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Symptoms: Afternoon 10/21: Chills, uncontrollable shaking; nausea; asthma exacerbation/shortness of breath (PFR dropped from 290 before flu shot to 240 on 10/22 a.m.). Morning 10/22: fever 102.2 (highest). Fatigue, weakness, anorexia. Didn't eat for > 1 day. Felt unstable, maybe light-headed when I got up to go to the bathroom--used a walker; Afternoon: diarrhea while sleeping; After about 2 days arms and legs itched incessantly (no rash); then, itchy red rash patch behind left knee; some itchy red spots around right ankle. Treatments: Acetaminophen TID for 3 days. Albuterol, 2 puffs TID or BID for 10 days; Flovent 110, 4 puffs BID for 2 days; 3 puffs BID for 2 days; 2 puffs for 2.5 days. (Ran out of Flovent; then used Arnuity Ellipta again.) Peak flow normal after 5 days, but I still had chest congestion. Rash: applied cortisone cream; rash lasted about 1.5 days. I was in bed for >2 days. I didn't feel fully recovered until about 6 days. I have never had any reaction except local to any immunization I have received over decades.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Tremor, Walking aid user
Clinical narrative: Symptoms: Afternoon 10/21: Chills, uncontrollable shaking; nausea; asthma exacerbation/shortness of breath (PFR dropped from 290 before flu shot to 240 on 10/22 a.m.). Morning 10/22: fever 102.2 (highest). Fatigue, weakness, anorexia. Didn't eat for > 1 day. Felt unstable, maybe light-headed when I got up to go to the bathroom--used a walker; Afternoon: diarrhea while sleeping; After about 2 days arms and legs itched incessantly (no rash); then, itchy red rash patch behind left knee; some itchy red spots around right ankle. Treatments: Acetaminophen TID for 3 days. Albuterol, 2 puffs TID or BID for 10 days; Flovent 110, 4 puffs BID for 2 days; 3 puffs BID for 2 days; 2 puffs for 2.5 days. (Ran out of Flovent; then used Arnuity Ellipta again.) Peak flow normal after 5 days, but I still had chest congestion. Rash: applied cortisone cream; rash lasted about 1.5 days. I was in bed for >2 days. I didn't feel fully recovered until about 6 days. I have never had any reaction except local to any immunization I have received over decades.