chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Approximately 4.5 hours after the dose he complained of a headache and nausea.; Approximately 4.5 hours after the dose he complained of a headache and nausea.; Approximately 5.5 hours after the dose he vomited.; This spontaneous report was received from a company representative refers to her son a 13-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-MAY-2023, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.   On 02-MAY-2023 (approximately 4.5 hours after the dose) the patient experienced headache, and nausea. On the same day, (approximately 5.5 hours after the dose) the patient experienced vomiting. The outcome of headache, vomiting and nausea was unknown.  The causality assessment was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: seriousness for facial and throat swelling; seriousness for facial and throat swelling; This serious case was reported by a consumer and described the occurrence of facial swelling in a 71-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25-APR-2023, the patient received the 2nd dose of Shingles vaccine. On 29-APR-2023, 4 days after receiving Shingles vaccine, the patient experienced facial swelling (Verbatim: seriousness for facial and throat swelling) (serious criteria clinically significant/intervention required and other: Serious as per reporter) and throat swelling (Verbatim: seriousness for facial and throat swelling) (serious criteria clinically significant/intervention required and other: Serious as per reporter). The patient was treated with methylprednisolone. On 30-APR-2023, the outcome of the facial swelling and throat swelling were resolved (duration 1 day).   It was unknown if the reporter considered the facial swelling and throat swelling to be related to Shingles vaccine.  It was unknown if the company considered the facial swelling and throat swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAY-2023 The patient experienced facial and throat swelling and urgent care issued Methylprednisolone tablets. The symptoms lasted for 36 hours. The reporter consented to follow up via email.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bite, COVID-19, Discomfort, Herpes zoster, Rash macular
Clinical narrative: Discomfort; form as welts, bites, bumps, sores; red bump on right chest, abdomen, red flat dot; Covid; red spots on arm, chest, bites, bumps, sores; got vaccines, got shingles; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In OCT-2022, the patient received the 1st dose of Shingrix (unknown arm). In JAN-2023, the patient received the 2nd dose of Shingrix (unknown arm). In APR-2023, between 5 and 6 months after receiving Shingrix and between 2 and 4 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: got vaccines, got shingles) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and red spotty rash (Verbatim: red spots on arm, chest, bites, bumps, sores). On an unknown date, the patient experienced discomfort (Verbatim: Discomfort), welts (Verbatim: form as welts, bites, bumps, sores), local swelling (Verbatim: red bump on right chest, abdomen, red flat dot) and covid-19 (Verbatim: Covid). The outcome of the vaccination failure, discomfort, welts, local swelling and covid-19 were unknown and the outcome of the shingles was not reported and the outcome of the red spotty rash was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, discomfort, red spotty rash, welts, local swelling and covid-19 to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, discomfort, red spotty rash, welts, local swelling and covid-19 to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 01-May-2023 The patient received his first Shingrix vaccine in October 2022, in an unknown arm and his second Shingrix vaccine in January 2023, in an unknown arm.  In April 2023, he first discovered a few raised red bumps on his right arm and one raised red bump on his right chest.  The reporter said couple days later there were about 6 raised red bumps on his right abdomen.  The patient states that there was no pain or itching.  He tested positive for Covid, so he went to the urgent care to receive medication for Covid and while there he mentioned to the doctor about the raised red bumps.  The doctor confirmed the raised red bumps were shingles.  The red raised bumps appeared before Covid was positive.  The doctor did not prescribe any medication for shingles.  The caller reports the all the praised red bumps had resolved or were just a red flat dot.  The reporter was very pleased he was spared the horrors of shingles pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash papular, SARS-CoV-2 test positive, Swelling, Urticaria, Vaccination failure
Clinical narrative: Discomfort; form as welts, bites, bumps, sores; red bump on right chest, abdomen, red flat dot; Covid; red spots on arm, chest, bites, bumps, sores; got vaccines, got shingles; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In OCT-2022, the patient received the 1st dose of Shingrix (unknown arm). In JAN-2023, the patient received the 2nd dose of Shingrix (unknown arm). In APR-2023, between 5 and 6 months after receiving Shingrix and between 2 and 4 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: got vaccines, got shingles) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and red spotty rash (Verbatim: red spots on arm, chest, bites, bumps, sores). On an unknown date, the patient experienced discomfort (Verbatim: Discomfort), welts (Verbatim: form as welts, bites, bumps, sores), local swelling (Verbatim: red bump on right chest, abdomen, red flat dot) and covid-19 (Verbatim: Covid). The outcome of the vaccination failure, discomfort, welts, local swelling and covid-19 were unknown and the outcome of the shingles was not reported and the outcome of the red spotty rash was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, discomfort, red spotty rash, welts, local swelling and covid-19 to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, discomfort, red spotty rash, welts, local swelling and covid-19 to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 01-May-2023 The patient received his first Shingrix vaccine in October 2022, in an unknown arm and his second Shingrix vaccine in January 2023, in an unknown arm.  In April 2023, he first discovered a few raised red bumps on his right arm and one raised red bump on his right chest.  The reporter said couple days later there were about 6 raised red bumps on his right abdomen.  The patient states that there was no pain or itching.  He tested positive for Covid, so he went to the urgent care to receive medication for Covid and while there he mentioned to the doctor about the raised red bumps.  The doctor confirmed the raised red bumps were shingles.  The red raised bumps appeared before Covid was positive.  The doctor did not prescribe any medication for shingles.  The caller reports the all the praised red bumps had resolved or were just a red flat dot.  The reporter was very pleased he was spared the horrors of shingles pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Had both shots, now have shingles/suspected vaccination failure; Shingles, very mild case; first they itched; Light case of pain; 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 (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In MAR-2023, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced shingles (Verbatim: Shingles, very mild case), pruritus (Verbatim: first they itched) and pain (Verbatim: Light case of pain). On an unknown date, the patient experienced vaccination failure (Verbatim: Had both shots, now have shingles/suspected vaccination failure) (serious criteria GSK medically significant). The patient was treated with lidocaine. The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pruritus was recovered/resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 31-March-2023 The case was received from the patient via interactive digital media. The patient had both shots in 2020 and now had shingles, a very very mild case. The patient stated that at first they itched and got a tube if lidocaine, that helps the numb the area. Itching gone now and the patient had a very light case of pain. The patient was glad he or she got the vaccine. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had Vx and still got shingles/Suspected Vaccination failure; Still got shingles; Not as painful since had shot; 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had Vx and still got shingles/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Still got shingles) and pain (Verbatim: Not as painful since had shot). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient interactive digital media. The patient had the shingle vaccines and still got shingles.  The patient stated that it was probably not as painful since he/she had the shot.  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. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR064976, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR064976:Same reporter - Mother case
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shot and has had shingles./Suspected Vaccination failure; Shingles back to back; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot and has had shingles./Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles back to back). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient's son/daughter interactive digital media. The reporter's mother had the shot and has had shingles back to back, had last month and again now (at the time of reporting). 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. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR064971, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR064971:Same reporter
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Received vaccine after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Haemophilus influenzae type b vaccine (batch number 242A7) for prophylaxis.   On 31-DEC-2022, the patient received Haemophilus influenzae type b vaccine. On an unknown date, an unknown time after receiving Haemophilus influenzae type b vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccine after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR065353:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included covid-19 (recovered from Covid-19 (Corona) infection). Previously administered products included Pfizer Covid-19 vaccine (three total shots of the Pfizer Covid-19 vaccine (dates not provided)).   On an unknown date, the patient received Flu vaccine (unknown arm). On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced pain in arm (Verbatim: Arm pain). The outcome of the pain in arm was resolved (duration 1 day).   The reporter considered the pain in arm to be related to Flu vaccine.     The company considered the pain in arm to be related to Flu vaccine.   Linked case(s) involving the same patient:  US2023063076   Additional Information: GSK Receipt Date: 28-APR-2023 The patient self-reported this case. The patient reported that he experienced arm pain of the injected arm but he did not report it because the pain was gone in a day. It was similar to the pain level that he has felt after receiving [unspecified] flu shot. The reporter did consent to follow up. For tolerance to the Shingrix dose refer case US2023063076.; Sender's Comments:  US-GSK-US2023063076:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Fatigue, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: Extreme fatigue; Sore arm; Nausea; Flu like symptoms; Pain in belly; This non-serious case was reported by a consumer via sales rep and described the occurrence of fatigue 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 fatigue (Verbatim: Extreme fatigue), pain in arm (Verbatim: Sore arm), nausea (Verbatim: Nausea), influenza-like symptoms (Verbatim: Flu like symptoms) and abdominal pain (Verbatim: Pain in belly). The outcome of the fatigue, pain in arm, nausea, influenza-like symptoms and abdominal pain were not reported.   It was unknown if the reporter considered the fatigue, pain in arm, nausea, influenza-like symptoms and abdominal pain to be related to Shingrix.     It was unknown if the company considered the fatigue, pain in arm, nausea, influenza-like symptoms and abdominal pain to be related to Shingrix.   Additional Information: GSK receipt date: 01-MAY-2023 The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: Throat hurts; Arm hurts; Head hurts; Feel very tired; Not hungry; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of throat pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 05-APR-2023, the patient received the 2nd dose of Shingles vaccine. On 05-APR-2023, less than a day after receiving Shingles vaccine, the patient experienced throat pain (Verbatim: Throat hurts), pain in arm (Verbatim: Arm hurts), headache (Verbatim: Head hurts), tiredness (Verbatim: Feel very tired) and appetite absent (Verbatim: Not hungry). The outcome of the throat pain, pain in arm, headache, tiredness and appetite absent were unknown.   It was unknown if the reporter considered the throat pain, pain in arm, headache, tiredness and appetite absent to be related to Shingles vaccine.     It was unknown if the company considered the throat pain, pain in arm, headache, tiredness and appetite absent to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and stated that it was strong and his or her throat, arm and head was hurts.  Patient was felt very tired and not hungry but it was better to receive the vaccine than to suffer for many months. Follow-up would not possible as no contact details were available.
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Product administered to patient of inappropriate age
Clinical narrative: 42 YO received Shingrix; Felt sick; This non-serious case was reported by a consumer and described the occurrence of sickness in a 42-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received Shingrix. In APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 42 YO received Shingrix). On an unknown date, the patient experienced sickness (Verbatim: Felt sick). The outcome of the sickness was resolved (duration 2 days) and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK receipt date:04-May-2023 This case was reported via companies. The patient felt sick for 2 days after vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter reported that his/her physician told him/her that if he/she had chickenpox as a child then he/she would not get shingles as an adult. The reporter stated that he/she knew the patient who received Shingles vaccine and shortly after that experienced shingles. The patient further stated that it was sounds like another fear inspired cash cow for certain chemical companies. The follow-up would not possible as no contact details were available. This case had been linked with US2023AMR064968 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR064968:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine five years ago and the only thing he/she had was a sore arm for a day. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that his or her physician told him or her that if he or she had chickenpox as a child then he or she would not got shingles as an adult. The reporter stated that he or she know the patient who received Shingles vaccine and shortly after that experienced shingles. The patient reported that it was sounds like another fear inspired cash cow for certain chemical companies. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR064963 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR064963:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site; Swelling at injection site; Tiredness, Slept like a baby; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date, refer case US2023AMR064993.).   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 pain (Verbatim: Pain at injection site), injection site swelling (Verbatim: Swelling at injection site) and tiredness (Verbatim: Tiredness, Slept like a baby). The outcome of the injection site pain, injection site swelling and tiredness were not reported.   It was unknown if the reporter considered the injection site pain, injection site swelling and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, injection site swelling and tiredness to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR064993   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she just received his or her second dose of Shingles vaccine. The patient experienced pain and swelling at the injection site which was bearable and tiredness. The patient stated that after received both the doses he or she was slept like baby. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR064993:Same reporter  - Case for 1st dose
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Received vaccine after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Haemophilus influenzae type b vaccine (batch number 242A7) for prophylaxis.   On 04-JAN-2023, the patient received Haemophilus influenzae type b vaccine. On an unknown date, an unknown time after receiving Haemophilus influenzae type b vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccine after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received Hib (Hiberix) (batch number J7CS5, expiry date 01-APR-2023) for prophylaxis.   On 28-APR-2023, the patient received Hiberix. On 28-APR-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-APR-2023 A reporter called to report that a patient received an expired dose of Hiberix.  They gave information about patient and vaccine and medical information was received. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. A patient received an expired dose of Hiberix, which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 26Apr2023, 2nd 28Apr2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 3-day-old female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 28-APR-2023, the patient received the 2nd dose of Engerix B. On 28-APR-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 26Apr2023, 2nd 28Apr2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 01-MAY-2023 The reporter reported that her daughter was born in last week and the hospital was did not documented the administrated dose of Hepatitis B vaccine, so the pediatrician office administered another dose of Engerix B on 28th April 2023.   The reporter stated that the hospital charged her for a hepatitis B vaccine, so the infant may have received a dose on 26th April 2023 at the hospital. The reporter did not had any lot number and expiration date information. The patient received 2nd dose of Engerix B early than recommended time frame, which led to shortening of vaccinations schedule.
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received Havrix expired dose; 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 73-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 01-MAY-2023, the patient received the 1st dose of Havrix. On 01-MAY-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: received Havrix expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-MAY-2023 The reporter reported that the patient received Havrix expired dose at the time of reporting. The reporter did not consent to follow up.  The patient received Havrix expired dose, which led to expired vaccine used.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Extra Fluarix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 13-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 953Y2) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced extra dose administered (Verbatim: Extra Fluarix administered). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAY-2023 The reporter reported that the patient received an extra dose of Fluarix vaccine. The reporter was looking for the guidance on the next steps. The patient received extra dose of Fluarix in error, which led to extra dose administered.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 07-AUG-2019, 2nd dose 26-MAR-2023; 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 25-year-old female patient who received HBV (Engerix B) (batch number AC397, expiry date 31-AUG-2023) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 7th August 2019).   On 26-MAR-2023, the patient received the 2nd dose of Engerix B. On 26-MAR-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 07-AUG-2019, 2nd dose 26-MAR-2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAY-2023 The reporter asked when should patient receive the 3rd dose of the Engerix-b. No reactions reported. The reporter consented to follow up via email. The patient received the 2nd dose of Engerix B late than recommendation, which led to drug dose administration interval too long.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 575HC, expiry date 28-FEB-2023) for prophylaxis.   On 25-APR-2023, the patient received Boostrix. On 25-APR-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine 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: 01-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The patient was administered expired Boostrix vaccine which led to expired vaccine used.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Administered an expired Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 01-MAY-2023, the patient received Infanrix (left deltoid) .5 mg/ml. On 01-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administered an expired Infanrix). 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: 01-MAY-2023 The patient received inadvertently an expired Infanrix, which led to expired vaccine used. The reporter did not consent to follow-up.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was due for DTap and HIB vaccines and was inadvertently administered Kinrix; 15 months old received Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 01-MAY-2023, the patient received Kinrix. On 01-MAY-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: patient was due for DTap and HIB vaccines and was inadvertently administered Kinrix) and inappropriate age at vaccine administration (Verbatim: 15 months old received Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The reporter did not have the lot or expiry date at time of call.  A 15-month old patient was due for DTap and HIB vaccines and was inadvertently administered Kinrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose /second dose on 11/1/2022; 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 50-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Patient received 1st dose of Twinrix on 25th October 2019).   On 01-NOV-2022, the patient received the 2nd dose of Twinrix. On 01-NOV-2022, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose /second dose on 11/1/2022). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-MAY-2023 The patient received 2nd dose of Twinrix late than recommended time frame, which led to drug dose administration interval too long. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2023, the patient received the 2nd dose of Shingrix. On 24-APR-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-MAY-2023 The reporter was husband of patient who reported that patient received dose of Shingrix. and developed a high fever that evening.  The fever subsided after a few days, but seemed to had never completely resolved.  The patient still had a one degree or so fever at the time of reporting. The reporter declined to provide any of their or the patient's information. All information provided was reported. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Decreased immune responsiveness, Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Postherpetic neuralgia.; Weakened immune system; Got 2 doses, got shingles/ suspected Vaccination failure; Shingles; COVID; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number A4D72, expiry date 23-MAY-2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number J352N, expiry date 11-DEC-2021) for prophylaxis.   Concurrent medical conditions included immunosuppression.   On 11-SEP-2020, the patient received the 2nd dose of Shingrix (left deltoid). On 19-MAY-2020, the patient received the 1st dose of Shingrix (left deltoid). In DEC-2022, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced covid-19 (Verbatim: COVID). On 06-FEB-2023, the patient experienced vaccination failure (Verbatim: Got 2 doses, got shingles/ suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Postherpetic neuralgia.) and decreased immune responsiveness (Verbatim: Weakened immune system). The outcome of the vaccination failure and decreased immune responsiveness were unknown and the outcome of the shingles was resolved and the outcome of the post herpetic neuralgia was not resolved and the outcome of the covid-19 was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, covid-19 and decreased immune responsiveness to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia, covid-19 and decreased immune responsiveness to be related to Shingrix. It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-MAY-2023 The reporter enquired regarding any data on revaccination or giving an additional dose of Shingles after 2 doses. The reporter reported that an immunocompromised adult patient over 55 years old two years after receiving the 2 doses of Shingrix had Shingles and asked for guidance. The patient did have COVID and thought this may have contributed to the weakened immune system as well.  The patient had recovered from Shingles but had Postherpetic neuralgia. The reporter did not consent to follow up. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; 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 17-month-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 01-MAY-2023, the patient received Infanrix. On 01-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used). 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: 03-MAY-2023 Director of Operations of a community health center reported that patient was administered a dose of Infanrix which had an expiration date of 29Apr2023. Reporter was unsure which dose in the series this was for the patient. At the time of reporting, the dose has not been repeated. The reporter consented to follow up. The patient received a dose of Infanrix which was already expired, which led to the expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient missed the second dose /late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Patient missed the second dose /late second 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: 03-MAY-2023 The pharmacist asked information about a patient who receive the 1st dose Twinrix. The patient missed the second dose (1 month after first dose). The reporter asked how to proceed with patient vaccination. The reporter did not provided information about the first dose given (lot number, exp date). The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: M
Vaccine: DTAP
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 17-month-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30-APR-2023) for prophylaxis.   On 02-MAY-2023, the patient received the 4th dose of Infanrix. On 02-MAY-2023, an unknown time after receiving Infanrix, 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: 03-MAY-2023 The reporter was nurse administrator. The reporter reported that one of the nurses at their facility administered a dose of Infanrix, which had an expired. This was the patient's fourth dose in the series. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient had received an expired dose of Infanrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient never got 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose 2 years ago from reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient never got 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2023 The pharmacist reported that a patient who got the first dose of shingrix 2 years ago and never got the 2nd dose. The patient not immunocompromised. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Infanrix 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 4-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 02-MAY-2023, the patient received Infanrix. On 02-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Infanrix 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: 03-MAY-2023 The reporter informed that a dose of Infanrix administered to a patient but such dose had already expired. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. A dose of Infanrix administered to a patient but such dose had already expired, which led to expired vaccine used.