chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Got them 6 months after got shot/Suspected vaccination failure; got them on fore head, back ofneck; A lot of itching; very little 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.  On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got them 6 months after got shot/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got them on fore head, back ofneck), pruritus (Verbatim: A lot of itching) and pain (Verbatim: very little pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus and pain were not reported.  It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine.  Additional Information: GSK receipt date: 25-APR-2023 This case was reported by the patient via interactive digital media. The patient had stated that, he/she had got them on his/her fore head, back of his/her neck 6 months after he/she got the Shingles shot. Pretty much just had a lot of itching very little pain. The physician had said because, he/she had got the shot already it helped with them not being too painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Insomnia, Pain, Peripheral swelling
Clinical narrative: It hurts like heck; Arm swollen; Hot; Couldn't sleep at all that night; Chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 (Verbatim: It hurts like heck), swelling arm (Verbatim: Arm swollen), feeling hot (Verbatim: Hot), insomnia (Verbatim: Couldn't sleep at all that night) and chills (Verbatim: Chills). The outcome of the pain, swelling arm, feeling hot, insomnia and chills were not reported.   It was unknown if the reporter considered the pain, swelling arm, feeling hot, insomnia and chills to be related to Shingles vaccine.     It was unknown if the company considered the pain, swelling arm, feeling hot, insomnia and chills to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 24-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that, the vaccine was a killer. The patient  just got his/her and it hurts like heck, arm swollen and hot, couldn't sleep at all that night, chills. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Product storage error, Underdose
Clinical narrative: Adult received Engerix 10mcg; Adult received Engerix 10mcg; This non-serious case was reported by a nurse via sales rep and described the occurrence of accidental underdose in a 61-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Previously administered products included Engerix Adult (received 1st dose of Engerix 20 mcg in January 2023).   In FEB-2023, the patient received the 2nd dose of Engerix B pediatric 10 mcg/mg. In FEB-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Adult received Engerix 10mcg) and adult use of a child product (Verbatim: Adult received Engerix 10mcg). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 At the time of second dose inadvertently administered pediatric dose with 10 mcg. The reporter informed that the error not due to packaging or labeling of GSK product but on human error and way in which they label and stored their vaccines. They had plan corrective action to avoid errors in future. The reporter understands that dose 2 did not count and would be repeated at today's (reporting day) visit and would complete the schedule.  The reporter consented to follow up. The adult patient received pediatric dose of Engerix B, which led to accidental underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: ended up with shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: ended up with 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: 24-MAR-2023 This case was reported by a patient's friend via interactive digital media. The reporter sated that he/she had several friends and family members that had shingles. The reporter stated that one had seen how it affected a patient and thought she would get the shingles vaccine. The patient ended up with shingles a few weeks later and it was bad.  The reporter further stated that what had happened to vaccines. They were for preventing infection once upon a time and many diseases were eradicated by vaccines and that was no longer true. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurt like the devil; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurt like the devil). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-MAR-2023 This case was reported by patient via interactive digital media. The patient just got his/her second Shingles vaccine. The patient stated that it hurt like the devil but nothing compared to the pain of shingles. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (that was miserable). Previously administered products included Shingrix with an associated reaction of illness (received 1st dose on an unknown date, refer link case US2023AMR060416 ).   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 sickness (Verbatim: sick). Rechallenge with Shingrix was positive. The outcome of the sickness was not reported.   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.   Linked case(s) involving the same patient:  US2023AMR060416   Additional Information: GSK receipt date: 22-APR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she was sick after each dose of Shingrix shot but, he/she would take that over than having shingles again. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR060416:dose 1, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: felt sick; chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had the first vaccination back in the day).   In MAR-2023, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: felt sick) and chills (Verbatim: chills). The outcome of the feeling unwell and chills were resolved.   It was unknown if the reporter considered the feeling unwell and chills to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell and chills to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2023AMR060509   Additional Information: GSK Receipt Date: 22-APR-2023 This case was reported by the patient via interactive digital media. The patient received first dose of Shingles vaccine back in the day, and felt sick with chills both times, but short lasting.  The patient was glad that it was over. The patient had seen first hand how bad shingles could be. Follow-up would not possible, as no contact details were available. For tolerance of 2nd dose, refer case US2023AMR060509.; Sender's Comments:  US-GSK-US2023AMR060509:Same patient
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; feeling run down; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: sore arm) and fatigue (Verbatim: feeling run down). The outcome of the pain in arm and fatigue were recovered/resolved (duration 2 days).   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and fatigue to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-APR-2023 The case was received from the patient via interactive digital media. The patient stated that the arm only hurts and felt run down the symptoms only last two days and she was telling us that you only need two doses your whole life.  The patient reported that make sure after getting the first dose that no longer than 6 months pass till the second dose within that timeframe you must get the second one otherwise the first dose loses its strength. The follow-up could not be possible as no contact details were available. The case was linked with case US2023AMR060553 and US2023AMR060554, reported by same reporter for her husband.; Sender's Comments:  US-GSK-US2023AMR060553:same reporter
Sex: M
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 male 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 unknown.   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: 22-Apr-2023 The case was received from the patient's wife interactive digital media. The reporter reported that the patient also got the shot and he only had sore arm. The reporter stated that make sure after you get the first dose that no longer than 6 months pass till the second dose within that time frame you must get the second one otherwise the first dose loses its strength. The follow-up could not be possible as no contact were available. The case was linked with case US2023AMR060545, reported by same reporter, for herself.; Sender's Comments:  US-GSK-US2023AMR060545:same reporter US-GSK-US2023AMR060547:deletion case US-GSK-US2023AMR060554:deletion case US-GSK-US2023AMR060545:
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; Agree to delete the cases US2023AMR060547 (reporter's case) and US2023AMR060554 (husband's case) as cases created in error. It is ok to keep one suspect with blank dose number. As it is not clear after which dose event occur and to retain only one case' please explain in narrative.; Sender's Comments:  US-GSK-US2023AMR060545:same reporter US-GSK-US2023AMR060547:deletion case US-GSK-US2023AMR060553:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: even after my first shot had then two more times until the newe; 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.   The patient's past medical history included shingles (had them 3 times) and pain (hurt like the devil all 3 times).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: even after my first shot had then two more times until the newe). The outcome of the shingles was recovered/resolved.   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: 26-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that even after his or her first shot had, then two more times until the new. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Nausea, Pain in extremity
Clinical narrative: Painful Left Arm; Nausea; Stomach Ache; Dizziness; 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.   Previously administered products included Covid shot (were less of a problem).   On 24-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Painful Left Arm), nausea (Verbatim: Nausea), stomach pain (Verbatim: Stomach Ache) and dizziness (Verbatim: Dizziness). The outcome of the pain in arm, nausea, stomach pain and dizziness were not reported.   It was unknown if the reporter considered the pain in arm, nausea, stomach pain and dizziness to be related to Shingles vaccine.  It was unknown if the company considered the pain in arm, nausea, stomach pain and dizziness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient and his/her daughter shingles vaccine on Friday. The patient's daughter had no reaction. The patient experienced painful left arm, nausea, stomach ache and dizziness. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Joint swelling, Mobility decreased, Pain, Pyrexia
Clinical narrative: Swollen from shoulder to psst elbow,; Fever; Painful; Could not use left arm; Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased 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 mobility decreased (Verbatim: Could not use left arm), sickness (Verbatim: Sick), swollen joints (Verbatim: Swollen from shoulder to psst elbow,), fever (Verbatim: Fever) and pain (Verbatim: Painful). The outcome of the mobility decreased was resolved (duration 12 days) and the outcome of the sickness was resolved (duration 2 weeks) and the outcome of the swollen joints, fever and pain were not reported.   It was unknown if the reporter considered the mobility decreased, sickness, swollen joints, fever and pain to be related to Shingles vaccine.     It was unknown if the company considered the mobility decreased, sickness, swollen joints, fever and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and told everyone to be prepared for sick for two weeks. The patient was unable to use his or her left arm for 12 days, hand swollen from shoulder to past elbow, had fever and it was very painful. The patient stated that he or she will never receive booster dose. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Oct2021, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (on October 2021 the patient received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Oct2021, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 The pharmacist reported that a patient received in October 2021 the first dose of Shingrix.  Till the reporting time the second dose was not administer to the patient.  The patient did not knew that it was 2-part vaccine and well no one at the pharmacy informed him/her. 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.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received Hib (Hiberix) (batch number 242A7) for prophylaxis.   On 21-FEB-2023, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a 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 was for one of 119 patients, reported by same reporter. The patient received unstable Hiberix vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received Hib (Hiberix) (batch number 242A7) for prophylaxis.   On 28-FEB-2023, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a 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 was for one of 119 patients, reported by same reporter. The patient received unstable Hiberix vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Age: 61.0
Sex: M
Vaccine: TDAP, TDAP, VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; Fever; Headache; Fatigue; This non-serious case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 477X5) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (ADACEL) for prophylaxis.   On 24-APR-2023, the patient received the 1st dose of Shingrix, Tdap Vaccine and ADACEL. In APR-2023, an unknown time after receiving Shingrix and Tdap Vaccine, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms), fever (Verbatim: Fever), headache (Verbatim: Headache) and fatigue (Verbatim: Fatigue). The outcome of the influenza-like symptoms, fever, headache and fatigue were not reported.   The reporter considered the influenza-like symptoms, fever, headache and fatigue to be related to Shingrix and Tdap Vaccine.     The company considered the influenza-like symptoms, fever, headache and fatigue to be related to Shingrix and Tdap Vaccine.   Additional Information: GSK Receipt Date: 26-APR-2023 On an unknown date, an unknown time after receiving Adacel, the patient experienced influenza-like symptoms, fever, headache and fatigue. The reporter though that the events were related to the product (Shingrix, Tdap and Adacel). The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 83-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 24-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a 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 was for one of 119 patients, reported by same reporter. The patient received unstable Tdap vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 63-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 10-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a 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 was for one of 119 patients, reported by same reporter. The patient received unstable Tdap vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 25-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 12-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a 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 was for one of 119 patients, reported by same reporter. The patient received unstable Tdap vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 48-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 13-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a 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 was 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-US2023AMR061580:same reporter US-GSK-US2023AMR062067:same reporter US-GSK-US2023AMR061582:same reporter US-GSK-US2023AMR061583:same reporter US-GSK-US2023AMR061581:same reporter US-GSK-US2023AMR062059:same reporter US-GSK-US2023AMR062065:same reporter US-GSK-US2023AMR062063:same reporter US-GSK-US2023AMR063143:Same reporter US-GSK-US2023AMR063144:Same reporter US-GSK-US2023AMR063146:Same reporter US-GSK-US2023AMR063147:Same reporter US-GSK-US2023AMR063148:Same reporter US-GSK-US2023AMR063149:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 40-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 16-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a 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 was 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-US2023AMR061580:same reporter US-GSK-US2023AMR062067:same reporter US-GSK-US2023AMR061582:same reporter US-GSK-US2023AMR061583:same reporter US-GSK-US2023AMR061581:same reporter US-GSK-US2023AMR062059:same reporter US-GSK-US2023AMR062065:same reporter US-GSK-US2023AMR062063:same reporter US-GSK-US2023AMR063143:Same reporter US-GSK-US2023AMR063144:Same reporter US-GSK-US2023AMR063145:Same reporter US-GSK-US2023AMR063147:Samer reporter US-GSK-US2023AMR063148:Same reporter US-GSK-US2023AMR063149:Same reporter US-GSK-US2023AMR063143:same reporter US-GSK-US2023AMR063144:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 46-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 26-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a 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 was 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-US2023AMR061580:same reporter US-GSK-US2023AMR062067:same reporter US-GSK-US2023AMR061582:same reporter US-GSK-US2023AMR061583:same reporter US-GSK-US2023AMR061581:same reporter US-GSK-US2023AMR062059:same reporter US-GSK-US2023AMR062065:same reporter US-GSK-US2023AMR062063:same reporter US-GSK-US2023AMR063143:Same reporter US-GSK-US2023AMR063144:Same reporter US-GSK-US2023AMR063145:Same reporter US-GSK-US2023AMR063146:Same reporter US-GSK-US2023AMR063148:Same reporter US-GSK-US2023AMR063147:Same reporter US-GSK-US2023AMR063143:same reporter US-GSK-US2023AMR063144:Same reporter US-GSK-US2023AMR063145:Same reporter US-GSK-US2023AMR063147:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 59-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 26-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a 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: 27.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received Pediatric dose; Adult received Pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B 10 mcg) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 19-APR-2023, the patient received Engerix B 10 mcg 10 mcg/mg. On 19-APR-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: Adult received Pediatric dose) and adult use of a child product (Verbatim: Adult received Pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The adult patient received Engerix-B 10 mcg, which led to underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Possible late 2nd dose; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2023, the patient received the 2nd dose of Shingrix. On 24-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 24-APR-2023 The reporter reported about a possible late 2nd dose of Shingrix.  The vaccine administration facility was the same as primary reporter. No adverse event details were available at that time. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Urticaria
Clinical narrative: patient with severe reaction/ Patient develops hives with vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of hives in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.  Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMO 23) for prophylaxis.  Additional patient notes included the patient was not allergic to COVID (Pfizer) vaccine.  On an unknown date, the patient received Flu vaccine and PNEUMO 23. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced hives (Verbatim: patient with severe reaction/ Patient develops hives with vaccine). The outcome of the hives was unknown.  It was unknown if the reporter considered the hives to be related to Flu vaccine.  It was unknown if the company considered the hives to be related to Flu vaccine.  Additional Information: GSK Receipt Date: 24-APR-2023 The reporter had reported that the he had a patient with severe reaction to flu and pneumo 23 and was not allergic to COVID (Pfizer). .  The patient had developed hives with vaccine. The reporter does not specified which flu vaccine.  No other information shared by field representative in agency. The reporter had consented to follow-up. It was unknown if the reporter had considered the adverse events to be related to PNEUMO 23 vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Lethargy
Clinical narrative: Lethargic after 1st dose; Never followed up to get 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of lethargy in a elderly female 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 1st dose of Shingrix and the did not receive 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lethargy (Verbatim: Lethargic after 1st dose) and incomplete course of vaccination (Verbatim: Never followed up to get 2nd dose). The outcome of the lethargy was resolved and the outcome of the incomplete course of vaccination was unknown.  It was unknown if the reporter considered the lethargy to be related to Shingrix.  It was unknown if the company considered the lethargy to be related to Shingrix.  Additional Information: GSK Receipt Date: 24-APR-2023 The patient had called at the time of reporting (today) and stated that, about 3.5 years ago she received the first dose of Shingrix on a Friday evening. The patient stated that, she never followed up to get her second dose. The patient stated that, she planned to get the second dose on 29 April 2023. The patient stated that the following Sunday after she received her first dose she felt lethargic. The reporter had denied consent to follow-up. Until the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Headache, Injection site pain
Clinical narrative: partial deafness left ear; pain at injection site; Headache; This serious case was reported by a consumer via call center representative and described the occurrence of deafness unilateral in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-APR-2023, the patient received the 2nd dose of Shingrix (left arm). In APR-2023, an unknown time after receiving Shingrix, the patient experienced deafness unilateral (Verbatim: partial deafness left ear) (serious criteria GSK medically significant). On 21-APR-2023, the patient experienced injection site pain (Verbatim: pain at injection site ) and headache (Verbatim: Headache). The outcome of the deafness unilateral was not resolved and the outcome of the injection site pain and headache were resolved (duration 2 days).   It was unknown if the reporter considered the deafness unilateral, injection site pain and headache to be related to Shingrix.     It was unknown if the company considered the deafness unilateral, injection site pain and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2023 The patient reported that he received Shingrix dose in left arm.  He experienced pain at injection site and a headache that lasted 2 days and resolved now.  He also experienced partial deafness in left ear that was not resolved. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 1-3 years ago, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 1-3 years ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 Pharmacist called to inform that some patients from the facility had received the 1st dose of Shingrix but didn't finish the series of time. According to pharmacist, the time from 1st to 2nd dose was around 1-3 years in different patients. The reporter did not consent to follow-up. HCP was not willing to provide information regarding patients, or adverse event information in general. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 66.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st doe 29Sep2022, 2nd 20Jan2023; 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 66-year-old female patient who received HAB (Twinrix) (batch number 2KE56, expiry date 22-SEP-2023) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 29th September 2022 from batch number 2KE56 with expiry date 22nd September 2023).   On 20-JAN-2023, the patient received the 2nd dose of Twinrix. On 20-JAN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st doe 29Sep2022, 2nd 20Jan2023). 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: 25-APR-2023 The pharmacist reported that the patient was back today for the 3rd dose of Twinrix. At the time of reporting, the third vaccine was not administered.  The reporter consented to follow up. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 24-APR-2023, the patient received the 1st dose of Twinrix. On 24-APR-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Twinrix 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: 25-APR-2023 The pharmacist reported that the patient inadvertently received an expired dose of Twinrix yesterday. No further details available at time of call, but pharmacist consented to follow up. The use of Twinrix, which was already expired on 1st January 2023, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received dose two of the series; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose of Shingrix in 2019.).   On 25-APR-2023, the patient received the 2nd dose of Shingrix. On 25-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient received dose two of the series). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 The pharmacist reported that patient forgot to return for the second dose within the approved timeframe. The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to drug dose administration too long. Pharmacist declined to provide further details on call. The reporter consented to follow up.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was administered Havrix that 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 47-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   On 25-APR-2023, the patient received Havrix. On 25-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Patient was administered Havrix that was expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The operations manager reported that a patient was administered Havrix that was expired on 16-Dec-2022. The vaccine administration facility was the same as Primary Reporter. The reporter consented to follow up via email.
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient got Infanrix instead of Boostrix; 13 YO patient was given Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old male patient who received DTPa (Infanrix) (batch number 9hp92, expiry date 21-APR-2024) for prophylaxis.   On 24-APR-2023, the patient received Infanrix. On 24-APR-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Patient got Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: 13 YO patient was given Infanrix). 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: 26-APR-2023 The reporter was medical assistant. The reporter reported that a 13 year old patient was given Infanrix instead of Boostrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The reporter reported that a 13 year old patient was given Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Boostrix subcutaneously instead of intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.  On 26-APR-2023, the patient received Boostrix (subcutaneous). On 26-APR-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Boostrix subcutaneously instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was unknown.  Additional Information: GSK receipt date: 26-APR-2023 A pharmacist called to inform that earlier that day, a patient had received a dose of Boostrix subcutaneously instead of intramuscularly. The reporter had consented to follow-up. The vaccine administration facility was the same as primary reporter. The patient was vaccinated via the subcutaneous route instead of the Intramuscular route, which had led to Intramuscular formulation administered by other route.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; 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) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 26-APR-2023, the patient received Havrix. On 26-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter asked information regarding the administration of an expired Havrix dose to a patient. The reporter asked how to proceed with this patient. The reporter did not provide information about the patient and during the call, permission for follow-up was not requested. The patient was administered with an expired Havrix dose to a patient, which led to expired vaccine used.