chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Illness, Pyrexia
Clinical narrative: sick; fever; tired; 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (in eye ) and shingles (in hair). Previously administered products included Shingles vaccine.   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 sickness (Verbatim: sick), fever (Verbatim: fever) and tiredness (Verbatim: tired). The outcome of the sickness and fever were not reported and the outcome of the tiredness was recovered/resolved (duration 1 week).   It was unknown if the reporter considered the sickness, fever and tiredness to be related to Shingles vaccine.   It was unknown if the company considered the sickness, fever and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot but got shingles anyway in his/her eye and hair.  The reporter stated that it was pretty awful.  The reporter further stated that the new vaccine was more effective they said and needed two doses.  The patient got his/her first dose of shingles vaccine last week and was sick with fever and so tired for a week. The reporter further stated that not sure if he/she would get the second one shingles vaccine.  The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Discomfort, Hyperaesthesia, Pain, Stress
Clinical narrative: burning; hot pain too sensitive to touch; sensitive to touch; affect sciatic nerve uncomfortable; under stress sick husband; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of burning sensation 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 burning sensation (Verbatim: burning), pain (Verbatim: hot pain too sensitive to touch), touch sensitivity increased (Verbatim: sensitive to touch), discomfort (Verbatim: affect sciatic nerve uncomfortable) and stress (Verbatim: under stress sick husband). The outcome of the burning sensation, pain, touch sensitivity increased, discomfort and stress were not reported.   It was unknown if the reporter considered the burning sensation, pain, touch sensitivity increased, discomfort and stress to be related to Shingles vaccine.   It was unknown if the company considered the burning sensation, pain, touch sensitivity increased, discomfort and stress to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that a burning, hot pain too sensitive to touch, it affected his/her sciatic nerve so was very uncomfortable.  The patient had the shingles vaccine also but had been under lots of stress with a very sick husband. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Muscle soreness in the area of the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 07-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced injection site muscle pain (Verbatim: Muscle soreness in the area of the shot). The outcome of the injection site muscle pain was not reported.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site muscle pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 08-Mar-2023 This case was reported by a patient via interactive digital media. The patient developed just a little muscle soreness in the area of the shot and nothing else happening yet. The patient stated that there would be a second of same in six months to finish up. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles; Pain; 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and pain (Verbatim: Pain). The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 9-Mar-2023 The case was received from the patient via interactive digital media. The patient asked that anyone had pain or shingles after shot. The patient did it was awful.  The patient got the shot because, how did they really know if they had chicken pox, it could be a mild case.  The patient was suppose to get second shot, but was afraid. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: shot made me sick as hell; 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 (Shingles vaccine) for prophylaxis.   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 sickness (Verbatim: shot made me sick as hell). The outcome of the sickness was recovered/resolved (duration 2 days).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by the patient via interactive digital media. The second Shingles shot made the patient sick as hell for 2 days but stated that it was worth it. The patient reported that just a heads up to plan your next day accordingly after the second shot and stated hopefully you would be okay. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Miliaria
Clinical narrative: Get heat rash, not fun; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of heat rash 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 heat rash (Verbatim: Get heat rash, not fun).The outcome of the heat rash was not reported.   It was unknown if the reporter considered the heat rash to be related to Shingles vaccine.  It was unknown if the company considered the heat rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient got both of his/her shingles shots.  The patient got heat rash which was not fun. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Varicella
Clinical narrative: Chickenpox 4th time; Before 50 YO got Vx; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chickenpox 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 chickenpox (Verbatim: Chickenpox 4th time) and inappropriate age at vaccine administration (Verbatim: Before 50 YO got Vx). The outcome of the chickenpox was not reported and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.     It was unknown if the company considered the chickenpox to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine years ago. The patient turned 50 years last year and freaking experienced fourth time chickenpox. The patient received Shingles vaccine who was younger than the indicated age which led to inappropriate age at vaccine administration. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Pain
Clinical narrative: umcomfortable after injection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles.   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 discomfort (Verbatim: umcomfortable after injection). The outcome of the discomfort was recovered/resolved.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.     It was unknown if the company considered the discomfort to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR041135   Additional Information: GSK receipt date: 09-Mar-2023  This case was reported by a patient via  interactive digital media. For patient's mom, shingles started her health decline. She had pain from them every day for the rest of her life. The patient received both of the shingles vaccines.  The new one is definitely uncomfortable for a few days after each injection, but nothing compared to what patient's suffered. The follow up would not possible, as no contact, details were available. For tolerance of 2nd dose refer case US2023AMR041135.; Sender's Comments:  US-GSK-US2023AMR041135:
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: Umcomfortable after injection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine with an associated reaction of discomfort (1st dose received on an unknown date, refer case US2023AMR041128). Family history included shingles (patient's mother).   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 discomfort (Verbatim: Umcomfortable after injection). Rechallenge with Shingles vaccine was positive. The outcome of the discomfort was recovered/resolved.  It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.  It was unknown if the company considered the discomfort to be related to Shingles vaccine.  Linked case(s) involving the same patient:  US2023AMR041128   Additional Information: GSK receipt date: 09-MAR-2023  This case was reported by a patient via interactive digital media. The patient stated that the new one was definitely uncomfortable for a few days after each injection, but nothing compared to what patient's mother had suffered. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR041128:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Shivered; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shivering in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shivering (Verbatim: Shivered). The outcome of the shivering was not reported.   It was unknown if the reporter considered the shivering to be related to Shingles vaccine.     It was unknown if the company considered the shivering to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received first dose of Shingles vaccine and it was a piece of cake. The patient stated that he/she received second dose of Shingles vaccine and experienced shivered all day but that was it. Patient was glad that he/she received the vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got it again; 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 it twice).   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: Got it again). 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: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received one dose of shingles vaccine and experienced shingles again. The patient stated that they did not tell him/her to receive a booster dose. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Side effects like the flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness 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 influenza like illness (Verbatim: Side effects like the flu). The outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.  It was unknown if the company considered the influenza like illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that the side effects to him/her like he/she had the flu for couple of days. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Have a small case around lower ribs; 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Have a small case around lower ribs).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: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that also after his/her shingles shot he/she did have a small case of shingles around his/her lower ribs but not severe. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 diarrhea (Verbatim: Diarrhea). The outcome of the diarrhea was not reported.   It was unknown if the reporter considered the diarrhea to be related to Shingles vaccine.     It was unknown if the company considered the diarrhea to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received second dose of Shingles vaccine and experienced some diarrhea. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: You will feel bad for a day or two after the shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  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 feeling bad (Verbatim: You will feel bad for a day or two after the shots). The outcome of the feeling bad was recovered/resolved.  It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  It was unknown if the company considered the feeling bad to be related to Shingles vaccine.  Additional Information: GSK receipt date: 09-MAR-2023  This case was reported by a patient via interactive digital media. The patient stated that, he/she did not know, how well the Shingles shots works, but if there was a chance it would help prevent them, he/she had made sure that, he/she would got it after he/she would become eligible when he/she had turned 50. It requires two shots about 3 months apart.  The patient stated you would feel bad for a day or two after the shots, but it sounded like it was a lot better than getting shingles. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Round scaly spots show up random; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin scaly in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In AUG-2022, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced skin scaly (Verbatim: Round scaly spots show up random). The outcome of the skin scaly was not recovered/not resolved.   It was unknown if the reporter considered the skin scaly to be related to Shingles vaccine.     It was unknown if the company considered the skin scaly to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. In 2022, the patient had round scaly spots show up in just random places, never hurt but some still had not healed. The follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Scond shot was bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (On an unknown date, received first shot of Shingles).   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 feeling bad (Verbatim: Scond shot was bad). The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that getting two shingle shots was a breeze compared to getting shingles.  The second shot was bad per say but well worth the protection. The follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose was given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 07-FEB-2023) for prophylaxis.   On 03-MAR-2023, the patient received Infanrix. On 03-MAR-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired dose was given). 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: 07-MAR-2023 HCP reporting via webform.  The reporter reported that an expired dose of Infanrix was given to the patient.  No additional adverse event information was available.  The reporter reported that an expired dose of Infanrix was given to the patient, which led to expired vaccine used. The case had been linked to US2023035910, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023035910:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: was administered an 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 patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 21-FEB-2023, the patient received Havrix. On 21-FEB-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: was administered an expired dose). 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: 07-MAR-2023 HCP reporting via webform. The reporter reported that patient was administered Havrix.  No additional adverse event information was available.  The reporter reported that patient was administered Havrix, which led to expired vaccine used. The case had been linked to US2023035908, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023035908:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: Stored in freezer and not administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error 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 intercepted product storage error (Verbatim: Stored in freezer and not administered).  The outcome of the intercepted product storage error was unknown.   Additional Information: GSK receipt date: 07-MAR-2023  The reporter was pharmacy manager.  The reporter reported Shingrix was accidentally stored in freezer and vaccine was not administered to patient. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019, not received the 2nd; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 0.5 ml on 19th August 2019 in an unknown arm intramuscularly).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2019, not received the 2nd).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 07-MAR-2023  The patient reported he did not believe he received the second Shingrix vaccine.  The patient did not want to share his date of birth (DOB). Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination. The reporter did not consent to follow-up and did not give permission to contact HCP.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero 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 16-year-old female patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 07-MAR-2023, the patient received Bexsero. On 07-MAR-2023, an unknown time after receiving Bexsero, [the patient experienced expired vaccine used (Verbatim: Expired Bexsero 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: 07-MAR-2023  The patient received a 7 days expired dose of Bexsero, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: Rotarix mixed with saline water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced wrong solution used in drug reconstitution (Verbatim: Rotarix mixed with saline water).         The outcome of the wrong solution used in drug reconstitution 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: 7-Mar-2023 The reporter told that it was not clear the date or to whom this vaccine was administered.  The reporter told that after doing the facility's inventory it was discovered that there was more diluent than powder component, leading to the conclusion that maybe one dose was reconstituted with an inadequate diluent. The reporter consented to follow-up. The patient received a dose of Rotarix which was reconstituted with saline water, which led to wrong solution used in drug reconstitution.
Sex: U
Vaccine: DTAP, DTAPIPV, HEP, MENB
Symptoms: Product storage error
Clinical narrative: Administration of vaccines after 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 an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patients received Infanrix, Kinrix, Engerix B and Bexsero. On an unknown date, an unknown time after receiving Infanrix, Kinrix, Engerix B and Bexsero, the patients experienced incorrect storage of drug (Verbatim: Administration of vaccines after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Mar-2023 The health care professional reported that there were multiple patients that might had received those vaccines after being exposed to below 32 Fahrenheit.  The reporter said that she spoke to someone that would send out a packet to her and she could gather patient details and mail information back. The reporter did not see a documentation trail and attempted to gather adverse event details and reporter declined.  No additional information provided. The reporter did not consent to follow-up. The patient received  Infanrix, Kinirx, Engerix-Band Bexsero below temperature excursion which led to incorrect storage of drug.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 2 weeks after 1st; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, [the patient experienced drug dose administration interval too short (Verbatim: 2nd dose 2 weeks after 1st).The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 07-MAR-2023. The patient's wife stated that her husband received second dose of Shingrix 2 weeks later his first dose. She did not have any further information about the vaccine in terms of lot number or expiration.  The reporter consented to follow up. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix given as 4th DTaP dose; Kinrix given to a 12-year-old; 2nd DTaP on 13Apr2010, 3rd on 01May2010 as Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Boostrix (An year ago on an unknown date, received a dose). Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (DTAP VACCINE).   On 04-NOV-2022, the patient received Kinrix. On 01-MAY-2010, the patient received Pediarix. On 01-MAY-2010, not applicable after receiving Kinrix and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too short (Verbatim: 2nd DTaP on 13Apr2010, 3rd on 01May2010 as Pediarix). On 04-NOV-2022, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix given as 4th DTaP dose) and inappropriate age at vaccine administration (Verbatim: Kinrix given to a 12-year-old). The outcome of the drug dose administration interval too short, inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 07-MAR-2023 A medical assistant supervisor reported that since there was an issue with the dose not being valid a 4th dose of Kinrix was given at 12 years. The patient received his 2nd and 3rd dose of DTaP as Pediarix. A year ago, patient had received Boostrix. The reporter consented to follow up. Since the patient received Kinrix as 4th dose of DTap vaccine at age 12 years, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. The patient received the 3rd dose of DTap (Pediarix) earlier than the recommended schedule, which led to shortening of vaccine schedule.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix 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 DTPa-HBV-IPV (Pediarix) (expiry date 05-MAR-2023) for prophylaxis.   On 06-MAR-2023, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, [the patient experienced expired vaccine used (Verbatim: Expired Pediarix 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: 07-MAR-2023  The pharmacist reported a patient was administered a dose of expired Pediarix, which led to expired vaccine used. The health care professional (HCP) did not had details at time of call but said he could get them, follow-up ok via email above in HCP details. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 3 yo and 7 months kid received Kinrix; fourth Dtpa dose and IPV which was 5th in series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 24-AUG-2022, the patient received Kinrix. On 24-AUG-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 yo and 7 months kid received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: fourth Dtpa dose and IPV which was 5th in series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-MAR-2023 The health care professionals reported the case for 3 year 7month old patient.  This was the patient fourth Dtap dose. Kinrix was also an the extra IPV which was 5th in series.  The reporter consented to follow up by email. A 3 year 7 month old patient received a Kinrix dose, which led to inappropriate age at vaccine administration. The patient received kinrix as the fourth Dtpa dose, which led to inappropriate schedule of vaccine administered.
Age: 18.0
Sex: M
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 18-year-old male patient who received HAV (Havrix 720) (batch number EP47E, expiry date 06-FEB-2023) for prophylaxis.   On 05-MAR-2023, the patient received Havrix 720. On 05-MAR-2023, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Expired Havrix 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: 07-MAR-2023  The pharmacist called on behalf of another pharmacy location where a patient was administered a dose of Havrix, which was expired. The pharmacist stated that the incident had been reported.   At the time of reporting, the vaccine had not been repeated. The reporter gave permission to follow-up with either him or the pharmacist listed under vaccine facility. The reporter consented to follow up. The patient was administered a dose of expired Havrix, which led to expired vaccine used.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-year-old male patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 07-MAR-2023, the patient received Havrix. On 07-MAR-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: 07-MAR-2023  The patient received Havrix pediatric expired dose, which led to expired vaccine used. The reporter consented to follow up. This case is linked with US2023035936, reported by same reporter.; Sender's Comments:  US-GSK-US2023035940:Same reporter
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 07-MAR-2023, the patient received Havrix. On 07-MAR-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: 07-MAR-2023  The patient received Havrix pediatric expired dose, which led to expired vaccine used. The reporter consented to follow up. This case is linked with US2023035936, reported by same reporter.; Sender's Comments:  US-GSK-US2023035936:Same reporter
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2nd dose given to a 3-year-old; Expired Pediarix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 05-MAR-2023) for prophylaxis.   On 07-MAR-2023, the patient received the 2nd dose of Pediarix. On 07-MAR-2023, an unknown time after receiving Pediarix, [the patient experienced inappropriate age at vaccine administration (Verbatim: 2nd dose given to a 3-year-old) and expired vaccine used (Verbatim: Expired Pediarix administered). The outcome of the inappropriate age at vaccine administration and expired vaccine used 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: 07-MAR-2023  A nurse informed that earlier that day a patient went to receive the 2nd dose of Pediarix at inappropriate age, but the dose administered was expired, which led to inappropriate age at vaccine administration and expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Blood immunoglobulin G increased, Off label use
Clinical narrative: Not need 2nd dose, high IgG levels; This non-serious case was reported by a physician via call center representative and described the occurrence of off label use in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced off label use (Verbatim: Not need 2nd dose, high IgG levels). The outcome of the off label use was unknown.   Additional Information: GSK receipt date: 7-Mar-2023 No further information shared or collected.  The permission for consent to follow up was not asked as adverse event was considered after call ended. The neurologist did titers for the patient (husband) and told him that he did not need a 2nd dose because he had high levels immunoglobulin G, which led off label use. As the neurologist suggested the patient to not to take 2nd dose of Shingrix just because of high level of immunoglobulin G, therefore it was considered that after knowing the schedule of Shingrix even though the health care professional suggest to not to take the dose and event was coded off label use.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: Waited several years to receive 2nd dose; shot flattened me 3 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of malaise in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In APR-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In APR-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Waited several years to receive 2nd dose). On an unknown date, the patient experienced malaise (Verbatim: shot flattened me 3 days).         Rechallenge with Shingrix was positive. The outcome of the malaise was recovered/resolved (duration 3 days) and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix and Shingrix.     It was unknown if the company considered the malaise to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 7-Mar-2023  The patient received the first dose and then waited several years to receive the second dose of Shingrix.  The patient gave him 4 stars because he was very professional easy to understand but the only thing was, he did not ask any questions other than when the patient got the shot and what where my name and address. The patient was not able to report that the shot flattened him/her for 3 days which was what it did the first one especially. The patient did not know the exact date of the first dose or the name of the facility.  The patient received the second dose of Shingrix later than the recommend interval, which led to lengthening of vaccine schedule. The reporter consented to follow-up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero 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 18-year-old male patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 21-FEB-2023) for prophylaxis.   On 06-MAR-2023, the patient received Bexsero. On 06-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero 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: 7-Mar-2023 The reporter consented to follow-up by email. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Vx given after temp excursion 70°F aprox; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a neonate male patient who received HBV (Engerix B pediatric) (batch number XNFT7, expiry date 31-MAR-2024) for prophylaxis.   On 07-MAR-2023, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced incorrect storage of drug (Verbatim: Vx given after temp excursion 70°F aprox). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 7-Mar-2023 The pharmacist reported a temperature excursion for on Engerix-B pediatric dose.  This unique vaccine was left at room temperature, around 70 degree Fahrenheit approximately but not sure, for no more than 5 minutes with no prior excursions.  The reporter had no data about exact temperature reached.  After this situation, the vaccines was administered to a new born on the day of reporting. The reporter consented to follow-up. The patient received a dose of Engerix B pediatric after temperature excursion, which led to incorrect storage of drug. As the age was zero day at the time of vaccination and there is medication error therefore to avoid report failure only age group was captured as neonate.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 05-MAR-2023) for prophylaxis.   On 07-MAR-2023, the patient received the 1st dose of Pediarix. On 07-MAR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Pediarix 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: 7-Mar-2023 Information for the adverse event was collected and the medical information was read. They did not wish to receive the information via only means. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Pediarix, which led to expired vaccine used.