chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Influenza virus test positive
Clinical narrative: tested positive for the flu; Initial information received on 27-Dec-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who had tested positive for the flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date in November 2024, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient tested positive for the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Reporter stated that, flu vaccine that was given to my son at the Pediatric office back in November. I'd like to obtain more information about the influenza vaccine and the virus strains. I understand that there are four or more strains of mutations out there and your vaccine is a 1:4 ratio, which I am trying to connect the dots. The reason is that my son tested positive for the flu and has been taking Tamiflu for 6 days and has not been better.     Relevant laboratory test results included: Influenza virus test - On an unknown date: Positive  Action take was not applicable.  The patient was treated with oseltamivir phosphate (tamiflu) for Influenza.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
Sex: M
Vaccine: FLUX
Symptoms: COVID-19
Clinical narrative: came down with covid; Initial information received on 31-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves Adult male patient who had came down with covid after receiving Influenza Vaccine.  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 unknown dose of suspect Influenza Vaccine produced by unknown manufacturer formulation, strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient had came down with covid (covid-19) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (came down with covid).  At time of reporting, the outcome was Unknown for the event came down with covid.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 28-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult female patient who experienced sick, after receiving vaccine Influenza Vaccine.  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 Vaccine produced by unknown manufacturer (form, strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient got sick (malaise) (latency: few days) following the administration of Influenza Vaccine.  Reportedly, the patient always got sick a few days after getting the vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: when took the vaccine for years, I came down with 2 weeks of flu every time; Initial information received on 10-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a Patient  This case involves Adult male patient who reported when he took the Influenza Vaccine for years, he came down with 2 weeks of flu every time.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient when took the vaccine for years, he came down with 2 weeks of flu every time (influenza) (unknown latency).  Reportedly, Ever since I stopped taking the flu vaccine, I never came down with the flu; When I took the vaccine for years, I came down with 2 weeks of flu every time. Go figure but I'm staying with my track record. Screw the flu vaccine and getting sick.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was 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.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: vaccine was given to patient without the diluent and sterile water was used with no adverse event; vaccine was given to patient without the diluent and sterile water was used with no adverse event; Initial information received on 30-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient to whom HIB (PRP/T) Vaccine [ACT-HIB] was given without the diluent and sterile water was used with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation.  On 30-Dec-2024, the patient received a dose 4 with dosage 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UK148AA, with unknown, strength and expiry) via unknown route in unknown administration site as immunization without the diluent and sterile water was used with no adverse event (product preparation error) (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.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: receiving an expired dose of act-hib with no reported adverse event; Initial information received on 02-Jan-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 years old female patient received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; and PNEUMOCOCCAL VACCINE 13V for Immunisation.  On 02-Jan-2025, the patient received an expired  dose of 0.5 ml, 1X (once) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK008AA and expiry 31-Dec-2024) with no reported adverse event (expired product administered) (latency same day) (strength and route: unknown) in the thigh NOS (not specified) for immunization.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: provided an expired ADACEL to a patient with no reported adverse event; Initial information received on 06-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 13 years old female patient who received an expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 of an expired diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection with standard strength (expiry date- 08-Dec-2024 and lot U7626AA) once via intramuscular route in the deltoid NOS (not otherwise specified) as Immunization with no reported adverse event (expired 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.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of expired ACTHIB vaccine with no reported adverse event; Initial information received on 06-Jan-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who had administration of expired HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Quadracel) for Immunisation; Polio vaccine inact 3v (Vero) (Ipol) for Immunisation; Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation; and Rotavirus vaccine live reassort oral 5v (Rotateq) for Immunisation.  On 03-Jan-2025, the patient received a  dose of 0.5 ml of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) lot UK008AA, Expiry date: 31-Dec-2024 (Expired product administered) via intramuscular route in the thigh nos(Not specified) (strength was unknown) for Immunization (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.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 06-Jan-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus vaccine live oral 1v (Rotarix) for Immunisation; and Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix) and PCV 20 for Immunisation.  On 03-Jan-2025, the patient received a dose 1 of 0.5 ml suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) lot UK008AA, Expiry date: 31-Dec-2024 (expired product administered) (strength was unknown) via intramuscular route in the thigh nos for Immunization.   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: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of expired vaccine with no reported adverse event; Initial information received on 07-Jan-2025 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves a 16 months old male patient who received expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine; pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20); and varicella zoster vaccine, all for Immunisation.  On 06-Jan-2025, the patient received expired unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength with lot UK005AA and expiry date 31-Dec-2024 via unknown route in unknown administration site for Immunization (expired product administered) (Latency same day).  Reportedly, Reporter stated that they gave an expired ACT HIB vaccine to a patient yesterday.   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: 1.83
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event
Clinical narrative: No Reaction to report
Age: 0.33
Sex: F
Vaccine: PNC15, RV1, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Varicella was ordered instead of Vaxielis administered in error.  We did not know that we made the error until our billing department notified us.  I contacted my supervisor, notified the ordering provider, and then contacted the patient right away and of the vaccine error.  We then scheduled patient to come in to get the correct vaccine.  I then reported the incident to our compliance department and now I am reporting it here.
Age: 21.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: pt fainted, but didn't loose consciousness. she usually faints or has dizziness after being stressed out or very nervous. she had job interview on Tue 1/7/2025 and very nervous since it's her last semester of college. pt was given a glass of water. she was able to sit by herself on chair while drinking glass of water, then was able to stand up on her own and waited for about 15-20 minutes while her mother was getting her Immunization.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT ACCIDENTALLY RECEIVED A SECOND DOSE OF AREXVY (1ST DOSE IN DECEMBER 2023 AND 2ND DOSE IN JANUARY 2025). PATIENT WAS INFORMED BUT LET US KNOW HE HASN'T EXPERIENCED ANY SIDE EFFECTS FROM INADVERTANTLY RECEIVING A SECOND DOSE OF THE VACCINE.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses of Arexvy; the first being on 1/22/24 and the second on 1/4/25
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received an inappropriate dose of Prevnar 20. The patient was vaccinated with Prevnar 20 on 01/07/25 but had previously already been vaccinated on 03/23/23. Record did not have history of the past vaccination. Also, due to the two-year time difference since last immunization, enterprise did not show history of this vaccination on the patient's profile. The patient was also asked about previous vaccinations prior to Prevnar 20 being administered. She did not recall receiving this vaccination in the past.  Patient is now aware of inappropriate dose given. She reports no ADRs and is not upset.
Age: 55.0
Sex: F
Vaccine: COVID19, FLU3, HEP, IPV, MMR, TDAP
Symptoms: Axillary pain, Tenderness
Clinical narrative: Patient came to pharmacy saying that her left arm hurts when she puts pressure on it and that it hurts under her armpit on 1/7/25 around 3pm. Looked as her armpit area and did not see any signs of swelling or redness. Looked up side effect profile of all vaccines administered on the the left arm and came to conclusion that it may be the Comirnaty vaccine that may have caused the symptoms patient was experiencing since it list axillary tenderness/swelling as possible side effects. Advised patient to use cold compress to help with pain or can take Tylenol if necessary and continue to monitor. If symptoms get worse advise patient to seek medical attention at clinic/ER since patient did not have primary doctor.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chillblains
Clinical narrative: Covid toes aka chilblains
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: pt came into pharmacy 5 days after injection to show a red patch about 2.5 inches in diameter on her left shoulder. non raised, red and patchy. pt described it as burning and itchy.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chemotherapy, Death, Endoscopy
Clinical narrative: Online report of death in EUA medical countermeasure recipient, a 69-year-old female recipient. She was receiving intravenous infusions on her hand on 12/4/24 and right forearm on 12/11/24 as a form of cancer treatment at Treatment Center and 04/22/24 victim received endoscopy at Hospital according to social media posts. On her social media post victim stated, "Just like the polio vaccine in 1959". No other post with inoculation info. On 08/12/21 victim posted about FDA decision to allow immune compromised to receive a "booster". Dose#1 Date 02/23/21 LOT#023M20A. VAX card list "MH"location likely hospital. Based on her social media posts she received at least 2 shots if not a third "booster"
Age: 1.42
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Gave Patient Expired HIB vaccine
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy, Skin irritation
Clinical narrative: Mild red 5 x 6 cm on right thigh no breaking skin and no infection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Facial paralysis, Pruritus, Skin exfoliation, Swelling face
Clinical narrative: September 28, 2024 - had two small swollen bumps on my nose. Nose began to turn red and swell that evening. Sept. 29, 2024: facial swelling on right side and above both eyes. Some itching and skin peeling. Went to an emergency clinic and was given Prednisone (10 mg/day for 5 days). Symptoms became worse, and the swelling moved to other areas of my face. Saw primary care doctor on 10/1/24. Was given higher dose of Prednisone, got blood tests. No response after 5 days on Prednisone, nothing abnormal on blood work. Given Doxycycline on 10/4/24. After 5 days, the swelling began to lessen. Within week, face was nearly back to normal with redness and some right side drooping of the cheek area still showing. It wasn't until the end of Oct. 2024 before all the redness and the drooping of my right cheek went away.
Age: 0.08
Sex: U
Vaccine: DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received first dose of PENTACEL (manufacturer: ), VAXNEUVANCE, and ROTATEQ at earlier than recommended age on 1/6/2025 due to a medication error as vaccines were intended for a different patient; received first dose of PENTACEL (manufacturer: ), VAXNEUVANCE, and ROTATEQ at earlier than recommended age on 1/6/2025 due to a medication error as vaccines were intended for a different patient; No symptoms reported. No additional AE details reported.; This spontaneous report was received from a registered nurse, referring to a 5-week-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were unknown.  On 06-JAN-2025, the patient was vaccinated with the first dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (lot # Y002963, expiration date 04-OCT-2026, 0.5 milliliter/dose; strength, route of administration and anatomical location were not provided), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot # 2073367, expiration date 26-NOV-2025, 2 milliliter/dose; strength was not provided) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (formulation, lot #, expiration date, dose, strength, route of administration and anatomical location were not provided) for prophylaxis at earlier than recommended age due to a medication error as vaccines were intended for a different patient (intended patient received all vaccines appropriately and no adverse event (AE) filed) (wrong patient received product and product administered to patient of inappropriate age). No symptoms reported. No additional AE details reported (no adverse event).   The outcome of product administered to patient of inappropriate age, no adverse event and wrong patient received product was unknown.
Age: 0.08
Sex: U
Vaccine: DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: received first dose of PENTACEL (manufacturer: ), VAXNEUVANCE, and ROTATEQ at earlier than recommended age on 1/6/2025 due to a medication error as vaccines were intended for a different patient; received first dose of PENTACEL (manufacturer: ), VAXNEUVANCE, and ROTATEQ at earlier than recommended age on 1/6/2025 due to a medication error as vaccines were intended for a different patient; No symptoms reported. No additional AE details reported.; This spontaneous report was received from a registered nurse, referring to a 5-week-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were unknown.  On 06-JAN-2025, the patient was vaccinated with the first dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (lot # Y002963, expiration date 04-OCT-2026, 0.5 milliliter/dose; strength, route of administration and anatomical location were not provided), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot # 2073367, expiration date 26-NOV-2025, 2 milliliter/dose; strength was not provided) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (formulation, lot #, expiration date, dose, strength, route of administration and anatomical location were not provided) for prophylaxis at earlier than recommended age due to a medication error as vaccines were intended for a different patient (intended patient received all vaccines appropriately and no adverse event (AE) filed) (wrong patient received product and product administered to patient of inappropriate age). No symptoms reported. No additional AE details reported (no adverse event).   The outcome of product administered to patient of inappropriate age, no adverse event and wrong patient received product was unknown.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertent administration of PENTACEL to an underaged patient. A 4-month-old baby should have received the vaccine, but a 5-week-old baby got it instead with no reported adverse event; Initial information received on 06-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 5 weeks old female patient to whom inadvertent administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] to an underaged patient. a 4-month-old baby should have received the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus vaccine live reassort oral 5v (Rotateq); and Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance).  On 06-Jan-2025, the 5 weeks old female patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (frequency: once, strength: standard, expiry date: 30-Apr-2025 and lot UK024AA) via intramuscular route in the left anterior thigh as immunization (product administered to patient of inappropriate age) to an underaged patient. a 4-month-old baby should have received the vaccine with no reported adverse event (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.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: inadvertent administration of PENTACEL to an underaged patient. A 4-month-old baby should have received the vaccine, but a 5-week-old baby got it instead with no reported adverse event; Initial information received on 06-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 5 weeks old female patient to whom inadvertent administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] to an underaged patient. a 4-month-old baby should have received the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus vaccine live reassort oral 5v (Rotateq); and Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance).  On 06-Jan-2025, the 5 weeks old female patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (frequency: once, strength: standard, expiry date: 30-Apr-2025 and lot UK024AA) via intramuscular route in the left anterior thigh as immunization (product administered to patient of inappropriate age) to an underaged patient. a 4-month-old baby should have received the vaccine with no reported adverse event (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.
Age: 27.0
Sex: F
Vaccine: COVID19, HEP, COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report received from a Physician.  A 27-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Jan2025 at 17:00 as dose 1, single (Lot number: LP1780) at the age of 27 years intramuscular, in left deltoid for covid-19 immunisation; hepatitis B vaccine rhbsag (yeast) (HEPLISAV B), in Jan2025 as dose 3, single) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "no side effects"; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization, reaction(s): "no side effects"; Bnt162b2 (Dose 3 (Booster), Single), for COVID-19 Immunization, reaction(s): "no side effects"; Bnt162b2 (Dose 4 (Booster), Single), for COVID-19 Immunization, reaction(s): "no side effects"; Hepatitis vaccine (Dose 1), for Immunization, reaction(s): "no side effects"; Hepatitis vaccine (Dose 2), for Immunization, reaction(s): "no side effects". The following information was reported: RASH (non-serious) with onset Jan2025, outcome "unknown". Therapeutic measures were not taken as a result of rash.  Additional information: Reporter stated, She got a rash pretty much from the vaccine. When probed to clarify that she got the rash after the administration of the Comirnaty: Reporter stated, Right and that was the same time she got the Hepatitis vaccine as well. Reporter was not sure. He knew that it can be the side effects of it but it was really hard to say, because before she got the Comirnaty vaccine, 4 times. For 4 times basically in 2 different countries and it was no side effects at all and she got her 2 Hepatitis vaccine here without any side effects as well, so it was kind of weird. She had first time that, so she did have her Hepatitis vaccine here without side effects and she did have 4 of Comirnaty vaccines before without side effects as well and the last one. Patient did not receive any other vaccine 4 weeks prior to the suspect vaccine. She was not treated for the event. It is self-remedy.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; They intended to give this patient one Varivax vaccine and one MMR II vaccine. They accidentally however gave two Varivax vaccinations in the patient's left leg; They intended to give this patient one Varivax vaccine and one MMR II vaccine. They accidentally however gave two Varivax vaccinations in the patient's left leg; This spontaneous report was received from an other health care professional and refers to a 13-month-old male patient.  The patient's historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On 27-DEC-2024 at 16:30, the patient was accidentally vaccinated with 2 doses of varicella virus vaccine live (Oka/Merck)(VARIVAX) Subcutaneous Injection, both doses administered in his left leg, lot number: Y011015 and expiration date reported as 18-JUN-2026 (strength, dose, and route of administration were not reported) as prophylaxis. The intention was giving this patient one varicella virus vaccine live (Oka/Merck)(VARIVAX) vaccine and one Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine. No adverse events had been reported by the patient's family thus far.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: passed out in the hallway/fainted after exiting the patient room; This spontaneous report has been received from a medical assistant via company employee referring to a 11-year-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  In approximately October 2024 (reported as approximately 3 months ago), the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered by a health professional at a pediatric clinic for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).  On the same day after receiving the injection, the patient waited 15 minutes and then fainted after exiting the patient room (also reported as passed out in the hallway of the clinic) (Syncope). On an unknown date, the patient recovered from the event. No additional adverse event (AE) or product quality complaint (PQC).  The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event of syncope was determined to be medically significant.  Lot # is being requested and will be submitted if received.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2501USA001362:0279790/02729790 US-009507513-2501USA001339:0279790/02729790
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Caller reported patient received 1st GARDASIL 9 vaccine on 10/31/2024, 2nd dose on 12/23/2024 and 3rd dose on 1/6/2025.; This spontaneous report was received from a pharmacist referring to a patient, age and gender was not reported.  Information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.  On 31-OCT-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis 0.5 ml (route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported).  On 23-DEC-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis 0.5 ml (route of administration, vaccination scheme frequency, anatomical location, were not reported, valid lot number Y010656 with an expiration date on 29-NOV-2026).   On 06-JAN-2025, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis 0.5 ml (route of administration, vaccination scheme frequency, anatomical location, were not reported, valid lot number Y010656 with an expiration date on 29-NOV-2026) (Inappropriate schedule of product administration). There was not adverse event reported.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: patient was administered with expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-month-old female patient who received MMR (Priorix) (batch number LG722, expiry date 01-DEC-2024) for prophylaxis.   On 11-DEC-2024, the patient received the 1st dose of Priorix. On 11-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: patient was administered with expired vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-DEC-2024 Nurse reported a patient was administered her first dose of Priorix, which had already expired, which led to an expired vaccine used.  Nurse called to inquire if the dose needs to be repeated after 28 days like other MMR vaccines would be if given after expiration. At the time of reporting, dose has not been repeated.  The vaccine administration facility was same as primary reporter.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Confusional state, Dizziness, Headache, Vision blurred
Clinical narrative: Dizziness, blurry vision, intense headache, confusion - resurrected concussion symptoms from past
Sex: U
Vaccine: RSV
Symptoms: Cough, Respiratory tract congestion, Rhinorrhoea, Sneezing
Clinical narrative: congestion; runny nose; little sneezing; coughing; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nasal congestion in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. In DEC-2024, an unknown time after receiving Arexvy, the patient experienced nasal congestion (Verbatim: congestion), runny nose (Verbatim: runny nose), sneezing (Verbatim: little sneezing) and cough (Verbatim: coughing). The outcome of the nasal congestion, runny nose, sneezing and cough were not reported.   It was unknown if the reporter considered the nasal congestion, runny nose, sneezing and cough to be related to Arexvy.     It was unknown if the company considered the nasal congestion, runny nose, sneezing and cough to be related to Arexvy.   Additional Information: GSK receipt date: 16-DEC-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The reporter reported that he/she went to lunch last Saturday on (14-December-2024) and he/she mentioned that he/she experienced congestion, runny nose, a little sneezing and coughing a little, same thing on 16th December 2024.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: patient accidentally received an expired dose of Priorix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received MMR (Priorix) (batch number D2LP3, expiry date 01-DEC-2024) for prophylaxis.   On 12-DEC-2024, the patient received the 1st dose of Priorix. On 12-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: patient accidentally received an expired dose of Priorix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-DEC-2024 A medical assistant was called to report that a patient accidentally received an expired dose of Priorix, which led to expired vaccine used. The reporter wished to know if there was any data and recommendations.  They were provided patient and vaccine data, declining to receive follow-up.
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the Arexvy adjuvant only; received the Arexvy adjuvant only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 17-DEC-2024, the patient received Arexvy. On 17-DEC-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: received the Arexvy adjuvant only) and inappropriate dose of vaccine administered (Verbatim: received the Arexvy adjuvant only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-DEC-2024 The pharmacist reported that yesterday (day before reporting) a patient received the Arexvy adjuvant only, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist immediately realized the error, then administer a fully reconstituted Arexvy vaccine to the patient. The reporter did not have the date of birth of the patient at the time of the call.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Pain
Clinical narrative: Bruising @ injection site. Painful arm which hindered arm movement. Injection site located in correct deltoid muscle position. Intermittent pain, not constant. Pain with or without movement. Not every day. Not radiating down arm or in shoulder. pinching pain @ injection site. Patient has called pharmacy almost every day since vaccination explaining issue with arm pain. We have counseled her on resting arm, icing injection site, taking Tylenol for pain. Patient also came back to pharmacy I visually inspected injection site. I saw a very pale blue bruise. Injection site looked at correct location at middle of deltoid muscle. She was advised to call her MD, which she did not. She did try to make apt at urgent care but was denied. We continue to counsel her daily on steps to relax arm, ice injection site and take Tylenol for pain. Pt is content and says pain is not everyday. There is no radiating pain down arm or in shoulder. Pain come and goes and is not dependent on movement. Pt states it is a pinching feeling at injection site. Pt calls almost daily and states the same facts. Ends conversation saying that we are so kind and she is grateful for all that we do for her.
Age: 38.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Extra dose administered
Clinical narrative: Scheduled for #2 Men B vaccine: Men A administerd. Over 30 d and #2. Men B vaccine also administered.
Sex: F
Vaccine: RSV
Symptoms: Blood test, Computerised tomogram head, Electric shock sensation, Facial paralysis, Foaming at mouth
Clinical narrative: First started to feel sick, then started to foam at mouth which lead to vomiting. Witnessed loosing facial tone, then looked like she left her self. Next she started to convulse. While this was going on I felt 3 different times on L. side of face similar to shocks, then passed out for several seconds.
Sex: F
Vaccine: RSV
Symptoms: Loss of consciousness, Malaise, Seizure, Vomiting
Clinical narrative: First started to feel sick, then started to foam at mouth which lead to vomiting. Witnessed loosing facial tone, then looked like she left her self. Next she started to convulse. While this was going on I felt 3 different times on L. side of face similar to shocks, then passed out for several seconds.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Blood test normal, Chest discomfort, Chest pain, Hypoaesthesia
Clinical narrative: - Sharp chest pain on/off - Pressure on chest - L. Arm numb. - E.R. Visit - no heart attack occurring unk. Diagnosis
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Wrong product administered
Clinical narrative: Pentacel ordered but Vaxelis administered
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Wrong product administered
Clinical narrative: Kinrix ordered but administered Infanrix and Polio vaccine as separate injections to patient
Age: 2.0
Sex: M
Vaccine: COVID19, DTPPVHBHPB, FLU3, HEPA, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 2 years old and a Covid vaccine for 12y+ was given in error. Patient tolerated vaccine well and not signs or symptoms of an adverse event at time of administration.
Age: 0.42
Sex: M
Vaccine: DTAP, PNC20, RV5
Symptoms: Wrong product administered
Clinical narrative: Vaxelis ordered but Infanrix administered on 11/4/24. Other components administered on 12/9/24.
Age: 0.58
Sex: M
Vaccine: DTAPIPV, PNC20, RV5
Symptoms: Wrong product administered
Clinical narrative: Kinrix administered instead of Vaxelis. Hib and Hep B vaccines administered on 12/19/24.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB, FLU3, PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 5 months old and received a Flulaval flu vaccine licensed for 6 months and older. No signs or symptoms of adverse event at time of administration.
Age: 6.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received COVID for ages 12 or more when 6 yo.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, FLU3, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient ordered 6month-4yo COVID vaccine but administered 12yo and older COVID vaccine.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: PPV23 administered on 10/28/24 and 12/31/24, instead of 2nd dose in 5 years per CDC (for 2-5 yo).  Last PCV was in 11/2022.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling at injection site.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Adverse event, Extra dose administered
Clinical narrative: It was brought to our attention after the vaccination that the patient had already received this vaccination on 9/7/23. Patient has not reported any adverse events or symptoms and currently states he is fine 1 day post 2nd vaccination.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: left arm hot red swollen painful
Age: 11.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Gave extra MMR. Should have only gotten varicella vaccine
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Product administered at inappropriate site
Clinical narrative: Patient had redness and swelling minimal pain no fever no other sx. Pt was given 2 vaccines in the same arm which caused a reaction.
Age: 32.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MMR and MMRV given at same time on same day. MMRV given to pt over 13.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was given 2 doses of Arexvy. The first dose administered 1/22/24 and the second dose administered 1/4/25.
Age: 1.08
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong vaccine given to client. No TX or adverse outcomes
Age: 31.0
Sex: F
Vaccine: RAB, YF
Symptoms: Injection site rash
Clinical narrative: Patient was screening for allergies/health history at Appt/RN, Dr. and received vaccines of Yellow Fever and Rabies 2 at Appt on 12/9/24.  Received Rabies  dose 1 and Hepatitis A vaccine at that appointment. Rescreened and received Yellow Fever and Rabies dose 2 vaccines at 12/16/24 appointment.  Within a few hours noticed quarter sized rash where YF was given.  Within a few days rash was 2 inches.  Mentioned rash at next appointment.  Doctor examined rash and advised postponing vaccines to January and to take an antihistamine (Zyrtec) and patient was given 1% hydrocortisone creme to place on rash.  Advised to call if any further reactions.  Patient followed instructions /took antihistamine and used creme.  At appointment  (1/9/25) patient screening, patient noted rash gone the next day after last  appointment after getting a little bigger.