chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called and reported inadvertent administration of PROQUAD and VARIVAX after a temperature excursion that occurred on 12NOV2024. Vaccines were administered to multiple patients with unknown demographics on 15NOV2024. No additional information was; This spontaneous report was received from a registered nurse referring to multiple patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 15-NOV-2024, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008283, expiration date 21-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number X006980, expiration date 07-MAR-2025 (doses and routes of administration not reported) both as prophylaxis (product storage error). No adverse event was reported.  The vaccines underwent a temperature excursion of -12.09 degrees Celsius for 1 hour.  Follow-up information was received from the registered nurse on 26-NOV-2024, regarding a 4-year-old male patient. Patient had 1 sister. The freezer's temperature excursion occurred on 12-NOV-2024 at 08:00, as a result of a data logger, so the nurse called the hospital's pharmacy to move the vaccines to a stable temperature, and they were transported safely, so RN called again to verify stabling of the vaccines, that were later deemed stable. So on 15-NOV-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (also reported as MMRV), administered intramuscularly (IM) in the upper right thigh by the trained nurse according to the instruction leaflet  at a private doctor's office/hospital (this patient had not received varicella virus vaccine live [oka/merck][VARIVAX]). The patient did not have any illnesses at the time of vaccination. This administration was billed to insurance.   The reporter considered the event to be recovered, to be not related to the suspect vaccine (conflicting information), and also considered the product storage error as an important medical event.
Age: 41.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; 41 year old patient was administered a dose of PROQUAD on 12/05/2024; This spontaneous report was received from a registered nurse and refers to a 41-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 05-DEC-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), lot #Y013576, expiration date: 03-FEB-2026, administered for prophylaxis (dose, strength, anatomical location, and route of administration were not provided) (Product administered to patient of inappropriate age). No reported signs/ symptoms of adverse effects.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller stated no patient symptoms have been reported; Nurse called to report an expired dose of PNEUMOVAX 23 was inadvertently administered to a patient. Caller stated product expired 11/24/2024 and was administered 12/2/2024. Caller stated no patient symptoms have been reported and product was never in; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-DEC-2024, the patient was inadvertently vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 dose, valid lot #X023559, expiration date reported and confirmed as 24-NOV-2024, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). It was stated that no symptoms had been reported (no adverse event) and the suspect vaccine was never involved in a temperature excursion.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; expired PNEUMOVAX 23 was given to a patient on 12/6/2024; This spontaneous report was received from a physician concerning to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 06-DEC-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection pre-filled syringe, 1 dosage form, lot #X023559, expiration date 24-NOV-2024 (dosage regimen, anatomical location and route of administration were not provided) administered for prophylaxis (expired product administered.)  No additional adverse events (AEs) were reported (no adverse event). No further information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product dose omission issue, Thyroid disorder, Vaccination failure, Weight decreased
Clinical narrative: thyroid way off; already had a vaccination for shingles; Weight loss; Shingles; Wrong drug; Missed dose; This serious case was reported by consumer via patient support programs. This female patient who received mepolizumab solution for injection in pre-filled pen for drug use for unknown indication was enrolled in study  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient received mepolizumab from an unknown date, for drug use for unknown indication. On an unknown date, an unknown time after starting mepolizumab and an unknown time after receiving Shingles vaccine, the patient experienced hypothyroidism (Verbatim: thyroid way off) (serious criteria GSK medically significant), vaccination failure (Verbatim: already had a vaccination for shingles) (serious criteria GSK medically significant), weight loss (Verbatim: Weight loss), shingles (Verbatim: Shingles), wrong drug administered (Verbatim: Wrong drug) and missed dose (Verbatim: Missed dose). The action taken with mepolizumab was unknown. The outcome of the hypothyroidism, weight loss, shingles, wrong drug administered and missed dose were unknown and the outcome of the vaccination failure was not reported.   Diagnostic results (reference ranges are provided in parenthesis if available):  Weight- 32 pounds.                                                                                                     It was unknown if the reporter considered the hypothyroidism, vaccination failure, weight loss and shingles to be related to mepolizumab, Nucala Autoinjector Device and Shingles vaccine.     The company considered the hypothyroidism to be unrelated to mepolizumab and Nucala Autoinjector Device. It was unknown if the company considered the weight loss and shingles to be related to mepolizumab, Nucala Autoinjector Device and Shingles vaccine. It was unknown if the company considered the vaccination failure to be related to Nucala Autoinjector Device and Shingles vaccine. It was unknown if the company considered the hypothyroidism to be related to Shingles vaccine.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.    GSK receipt date: 2-Dec-2024 Patient advised, her doctor gave her the wrong medicine and she lost thirty two pounds and she had thyroid doctors that don't know what to do. She might die tomorrow.  Her thyroid is way off. The last time her missed Nucala she got shingles and already had a vaccination for shingles and they thought she was gonna lose my eye.  She ended up in the emergency room.  They thought she was having a stroke.; Sender's Comments: Hypothyroidism  is an unlisted event which is considered unrelated to GSK drug Mepolizumab and mepolizumab autoinjector device US-GLAXOSMITHKLINE-US2024008739:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: thyroid way off; already had a vaccination for shingles; Weight loss; Shingles; Wrong drug; Missed dose; This serious case was reported by consumer via patient support programs. This female patient who received mepolizumab solution for injection in pre-filled pen for drug use for unknown indication was enrolled in study  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient received mepolizumab from an unknown date, for drug use for unknown indication. On an unknown date, an unknown time after starting mepolizumab and an unknown time after receiving Shingles vaccine, the patient experienced hypothyroidism (Verbatim: thyroid way off) (serious criteria GSK medically significant), vaccination failure (Verbatim: already had a vaccination for shingles) (serious criteria GSK medically significant), weight loss (Verbatim: Weight loss), shingles (Verbatim: Shingles), wrong drug administered (Verbatim: Wrong drug) and missed dose (Verbatim: Missed dose). The action taken with mepolizumab was unknown. The outcome of the hypothyroidism, weight loss, shingles, wrong drug administered and missed dose were unknown and the outcome of the vaccination failure was not reported.   Diagnostic results (reference ranges are provided in parenthesis if available):  Weight- 32 pounds.                                                                                                     It was unknown if the reporter considered the hypothyroidism, vaccination failure, weight loss and shingles to be related to mepolizumab, Nucala Autoinjector Device and Shingles vaccine.     The company considered the hypothyroidism to be unrelated to mepolizumab and Nucala Autoinjector Device. It was unknown if the company considered the weight loss and shingles to be related to mepolizumab, Nucala Autoinjector Device and Shingles vaccine. It was unknown if the company considered the vaccination failure to be related to Nucala Autoinjector Device and Shingles vaccine. It was unknown if the company considered the hypothyroidism to be related to Shingles vaccine.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.    GSK receipt date: 2-Dec-2024 Patient advised, her doctor gave her the wrong medicine and she lost thirty two pounds and she had thyroid doctors that don't know what to do. She might die tomorrow.  Her thyroid is way off. The last time her missed Nucala she got shingles and already had a vaccination for shingles and they thought she was gonna lose my eye.  She ended up in the emergency room.  They thought she was having a stroke.; Sender's Comments: Hypothyroidism  is an unlisted event which is considered unrelated to GSK drug Mepolizumab and mepolizumab autoinjector device US-GLAXOSMITHKLINE-US2024008739:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Injection site may have little sore; arm pain; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site may have little sore) and pain in arm (Verbatim: arm pain). The outcome of the injection site pain and pain in arm were resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site pain and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 11-NOV-2024 The patient reported that she received Shingrix vaccine and they mentioned that they did not really experience any side effects. The injection site might had been a little sore, but she also did arm the day before so that might be why her arms were so sore. The reporter mentioned that she went to her personal training session the next day and it was fine.
Sex: U
Vaccine: RSV
Symptoms: Cough, Wheezing
Clinical narrative: bad cough; Wheezing; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: bad cough) and wheezing (Verbatim: Wheezing). The outcome of the cough and wheezing were not reported.   It was unknown if the reporter considered the cough and wheezing to be related to Arexvy.     It was unknown if the company considered the cough and wheezing to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-NOV-2024 This case was reported by a patient via interactive digital media. The patient had a several bad cough and wheezing.  The patient asked any suggestions.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia, Scar, Skin burning sensation
Clinical narrative: Felt like lighter fluid was poured over my neck and shoulders and set ablaze; nerve pain; scars; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of burning sensation skin in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced burning sensation skin (Verbatim: Felt like lighter fluid was poured over my neck and shoulders and set ablaze), nerve pain (Verbatim: nerve pain) and scar (Verbatim: scars). The outcome of the burning sensation skin was not reported and the outcome of the nerve pain and scar were not resolved.   It was unknown if the reporter considered the burning sensation skin, nerve pain and scar to be related to Shingrix.     It was unknown if the company considered the burning sensation skin, nerve pain and scar to be related to Shingrix.   Additional Information: GSK receipt date: 13-NOV-2024 This case was reported by a patient via interactive digital media. The reporter reported that patient felt like lighter fluid was poured over neck and shoulders and set ablaze.  Still have the scars and nerve pain.  Patient get the vaccine annually because patient was never having that again.
Sex: F
Vaccine: RVX
Symptoms: Cough, Feeling abnormal, Malaise, Rhinorrhoea
Clinical narrative: hacking and coughing; Sick; covid; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: hacking and coughing) and sickness (Verbatim: Sick). The outcome of the cough was resolving and the outcome of the sickness was resolved (duration 2 weeks).   It was unknown if the reporter considered the cough and sickness to be related to RSV vaccine.     It was unknown if the company considered the cough and sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 15-NOV-2024 and 03-DEC-2024 The case was received from the patient via interactive digital media. The patient was reporter The reporter did and regret it as the patient got so sick for 2 weeks with a bad hacking cough, running nose and was just miserable. never again will the patient get any of those stupid shots. never got the covid shot but my husband did and they both got the covid that lasted for two weeks too these shots were dangerous.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: just some arm tenderness at sight of shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site tenderness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site tenderness (Verbatim: just some arm tenderness at sight of shot). The outcome of the injection site tenderness was not reported.   It was unknown if the reporter considered the injection site tenderness to be related to Shingles vaccine.     It was unknown if the company considered the injection site tenderness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-NOV-2024 This case was reported by a patient via interactive digital media The patient received 1st shot of Shingles vaccine and was fine and had second shot with just some arm tenderness at sight of shot.
Sex: F
Vaccine: RVX
Symptoms: Dizziness
Clinical narrative: dizzy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced dizziness (Verbatim: dizzy). The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to RSV vaccine.     It was unknown if the company considered the dizziness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 15-NOV-2024 The reporter reported that patient received RSV vaccine and got dizzy, a year later she still had not recovered.; Sender's Comments:  US-GSK-US2024AMR144410:same reporter
Sex: F
Vaccine: HPV2
Symptoms: Autoimmune thyroiditis
Clinical narrative: daughter developed Hashimotos; This serious case was reported by a consumer via interactive digital media and described the occurrence of hashimoto's disease in a female patient who received HPV 16-18 (Cervarix) for prophylaxis.   On an unknown date, the patient received Cervarix. On an unknown date, an unknown time after receiving Cervarix, the patient experienced hashimoto's disease (Verbatim: daughter developed Hashimotos) (serious criteria GSK medically significant). The outcome of the hashimoto's disease was not reported.   It was unknown if the reporter considered the hashimoto's disease to be related to Cervarix and Cervarix Pre-Filled Syringe Device.     The company considered the hashimoto's disease to be unrelated to Cervarix and Cervarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-DEC-2024 This case was reported by a patient via interactive digital media. The reporter reported that sadly they often only woke up when it happened to either us or someone close to us. The reporter was put off vaccine for about 8 years since the patient developed Hashimoto's after the Cervarix vaccination.; Sender's Comments: Autoimmune thyroiditis  is an unlisted event which is considered unrelated to GSK vaccine Cervarix and Cervarix PRE-FILLED SYRINGE DEVICE.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-NOV-2024 This case was reported by a patient via interactive digital media. The patient received all shingles shot and still had shingles. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(dose 1 and 2).
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccintion failure; got the worse case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccintion failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the worse case of shingles). The outcome of the vaccination failure and shingles were not reported.   The reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-DEC-2023 Patient got the double jab of Shingrix about 5 years ago and got the worst case of shingles a couple years later. Patient had no rash, but the worst back pain one could ever imagine. It came back a second time somewhere between 6 months and a year after the first bout, but it was not near as severe. Patient felt that Vaccine caused him to get it. This case is linked with the case US2023AMR187624 by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. US-GSK-US2023AMR187624:same reporter different patient
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Administration only of the Arexvy liquid portion; Administration only of the Arexvy liquid portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 10-NOV-2024, the patient received the 1st dose of Arexvy. On 10-NOV-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Administration only of the Arexvy liquid portion) and inappropriate dose of drug administered (Verbatim: Administration only of the Arexvy liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of drug administered were unknown.   Additional Information: GSK Receipt Date: 11-NOV-2024 Pharmacist reported that a patient was supposed to get a Shingrix vaccine and an Arexvy vaccine. The intern accidentally used the diluent for the Shingrix vaccine to mix the Arexvy and they gave the shot to the patient. Pharmacist thought that intern did not know that the Arexvy vaccine had to be mix, so she gave just the diluent of the Arexvy to the patient, instead of mixing it with the powder. Pharmacist wanted to know if they have to revaccinate the patient. Consented to follow up. Pharmacist mentioned that the patient did not get any Shingrix vaccine. No further information was provided. The Arexvy powder portion was mixed with the Shingrix liquid portion and then they administerrd only the Arexvy liquid portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.; 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 patient who received DTPa-HBV-IPV (Pediarix) (batch number 9552X, expiry date 26-OCT-2024) for prophylaxis.   On 11-NOV-2024, the patient received Pediarix. On 11-NOV-2024, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). 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: 11-NOV-2024 the reporter asking did had extended stability data studies for pediarix and the rotarix virus vaccines. Eleven days passed and gave vaccinations. The reporter was wonder if have extended stability data or should repeat the immunizations. The patient received Rotavirus vaccine which was not a GlaxoSmithKline product with the lot number 1979977 and expiration date 14-October-2024. The patient received expired Pediarix, which led expired vaccine used.
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: patient received adjuvant without the antigen; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4BN95, expiry date 25-OCT-2025) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient received adjuvant without the antigen) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-NOV-2024 The patient received adjuvant without the antigen during administration of vaccine Arexvy, which led inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter states the patient came back when mistake was found and received a correct dose.  Reporter has limited information concerning the incomplete dose of Arexvy. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: achiness; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In SEP-2024, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: achiness) and fever (Verbatim: fever). The outcome of the pain and fever were resolved.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.     It was unknown if the company considered the pain and fever to be related to Shingrix.   Additional Information: GSK Receipt Date- 12-NOV-2024 The reporter was the patient who called on the day of reporting asking about having side effects from the Shingrix vaccine. The patient received her 1st vaccine in September 2024 and was scheduled to get her 2nd vaccine on December 2024. The reporter called in response to having fever and achiness that has now subsided. The reporter would not give any details in regards to the vaccine.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong Product Used/when they should have been administered Tdap and IPV; 7 year old patient was administered a dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong product administered in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis.   On 28-OCT-2024, the patient received Kinrix. On 28-OCT-2024, an unknown time after receiving Kinrix, the patient experienced wrong product administered (Verbatim: Wrong Product Used/when they should have been administered Tdap and IPV) and inappropriate age at vaccine administration (Verbatim: 7 year old patient was administered a dose of Kinrix). The outcome of the wrong product 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: 12-NOV-2024 The patient was administered a dose of Kinrix at not recommended age, which led inappropriate age at vaccine administration. The patient should have been administered Tdap and IPV but the Kinrix dose made the patient's 5th dose of DTaP and 4th dose of IPV, which led wrong vaccine administered.  The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose not given in recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 41-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Second dose not given in recommended interval). The outcome of the incomplete course of vaccination 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-NOV-2024 The patient received 1st dose of Twinrix and second dose not given in recommended interval. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: a Hep A (Havrix), it said that it was expired; 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 2-year-old female patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 12-NOV-2024, the patient received Havrix. On 12-NOV-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: a Hep A (Havrix), it said that it was expired). 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-NOV-2024 The certified pharmacy technician reported that so what happened was that they had that vaccine and was a Hepatitis A (Havrix), it said that it was expired, like ten days ago, and they used it by accident and gave it to a patient, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered a dose of Havrix that had expired; 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 15-year-old male patient who received HAV (Havrix) (batch number 2X2EJ, expiry date 24-OCT-2024) for prophylaxis.   On 08-NOV-2024, the patient received Havrix. On 08-NOV-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Havrix that had expired). 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-NOV-2024  The other health professional reported that the patient was administered a dose of Havrix that had expired which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: patients don't always return for their 2nd dose after first dose; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: patients don't always return for their 2nd dose after first dose). The outcome of the incomplete course of vaccination 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: 13-NOV-2024 The physician reported that their patients didn't always return for their 2nd dose The reporter asked what was the effectiveness or efficacy of Bexsero 1st dose only and how long did the 1st dose of Bexsero antibodies last. Till the time of reporting, the patients did not receive the 2nd dose of Bexsero vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Maladministration of Havrix after the Expiration Date; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix pediatric) for prophylaxis.   On 14-NOV-2024, the patient received Havrix pediatric. On 14-NOV-2024, an unknown time after receiving Havrix pediatric, the patient experienced expired vaccine used (Verbatim: Maladministration of Havrix after the Expiration Date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-NOV-2024 The pharmacist reported that a patient received expired dose of Havrix pediatric vaccine, which led to expired vaccine used.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: a patient received an expired dose of Engerix-B.; 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 patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: a patient received an expired dose of Engerix-B.). 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- 14-NOV-2024 The reporter stated a patient received an expired dose of Engerix-B which led to expired vaccine used. The reporter did not have any details of the event, the vaccine may have been a month or 2 expired, and he was just calling to get recommendations.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: the dose was expired on 9th September 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HBV (Engerix B) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   On 08-NOV-2024, the patient received Engerix B. On 08-NOV-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: the dose was expired on 9th September 2024). 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: 14-NOV-2024 Nurse reported that a patient received an expired dose of Engerix B which led to expired vaccine used. The reporter asked that the dose was valid.  The vaccine administration facility was the same as primary reporter. The patient received an expire dose of Engerix B, which led to expired vaccine used.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second Late Dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number A2F3R, expiry date 26-OCT-2026) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2017).   On 14-OCT-2024, the patient received the 2nd dose of Shingrix. On 14-OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Second Late Dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 14-NOV-2024 The patient received 2nd dose at longer interval than recommended which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 0.67
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: and the second dose administered two weeks two days apart; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 8-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 724L5, expiry date 02-JUN-2025) for prophylaxis.   Concomitant products included Influenza vaccine inact split 3v (Flulaval).   On 10-OCT-2024, the patient received the 2nd dose of FluLaval 2024-2025 season. On 10-OCT-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced drug dose administration interval too short (Verbatim: and the second dose administered two weeks two days apart). The outcome of the drug dose administration interval too short 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: 14-NOV-2024 The second dose of FluLaval administered two weeks two days apart, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: a 4 month old patient received Kinrix; received Kinrix as their 2nd dose of DTaP and IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   On 15-OCT-2024, the patient received Kinrix. On 15-OCT-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 4 month old patient received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: received Kinrix as their 2nd dose of DTaP and IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 15-NOV-2024  The nurse reported that 4 month old patient received Kinrix as their 2nd dose of DTaP and IPV which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A patient who is under the age of 10 received the 1-vial presentation of Menveo; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a child patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: A patient who is under the age of 10 received the 1-vial presentation of Menveo). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 15-NOV-2024 The pharmacist reported that a patient who was under the age of ten received the 1 vial presentation of Menveo, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Maladministration After the Expiration Date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received MMR (Priorix) (expiry date 01-NOV-2024) for prophylaxis.   On 19-NOV-2024, the patient received Priorix. On 19-NOV-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Maladministration After the Expiration Date). 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: 19-NOV-2024  The nurse reported administration on the day of reporting an expired dose to a patient which led to expired vaccine used. The nurse wanted to know if this was a valid dose or should they call back the patient to receive another dose.
Age: 1.92
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: product was administered after being stored at inappropriate temperature; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 23-month-old male patient who received MMR (Priorix) (batch number LY377, expiry date 01-APR-2025) for prophylaxis.   On 07-NOV-2024, the patient received Priorix. On 07-NOV-2024, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: product was administered after being stored at inappropriate temperature). The outcome of the incorrect storage of drug 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: 19-NOV-2024 The nurse manager reported that their facility received 2 boxes of Priorix and did not realized they should be refrigerated, so the boxes were stored in the freezer for about a month.  They were exposed to a low of minus 23 degree Celsius and the product was administered to patient after being stored at inappropriate temperature, which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024144736:Same reporter/different patient US-GSK-US2024144737:Same reporter/different patient US-GSK-US2024144738:Same reporter/different patient
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 19-month-old female patient who received MMR (Priorix) for prophylaxis.   Previously administered products included MMR vaccine (received 2 doses on an unknown date, at an 6 months and 12 months of age).   On 07-NOV-2024, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug 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: 19-NOV-2024 The nurse reported that their facility received 2 boxes of Priorix and did not realize they should be refrigerated, so the boxes were stored in the freezer for about a month.  They were exposed to a low of minus 23 degree Celsius and the product was administered to patient after being stored at inappropriate temperature, which led to incorrect storage of drug. The reporter also states that this patient had already received Merck MMR vaccine at 6 months of age as well as at 12 months of age. The vaccine administration facility was the same as primary reporter. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024144734:Same reporter/different patient US-GSK-US2024144738:Same reporter/different patient US-GSK-US2024144737:Same reporter/different patient
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Maladministration of Priorix without the powder component (sterile water alone); Maladministration of Priorix without the powder component (sterile water alone); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult female patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis.   In NOV-2024, the patient received Priorix. In NOV-2024, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of Priorix without the powder component (sterile water alone)) and inappropriate dose of vaccine administered (Verbatim: Maladministration of Priorix without the powder component (sterile water alone)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: Follow up received on 19-NOV-2024 The medical assistance had recently found that an adult female patient, received Priorix sterile water diluent alone without the powder portion which led to Inappropriate dose of vaccine administered and inappropriate preparation of medication. The healthcare professional believed this happened last week. The vaccine administration facility was the same as primary reporter.