chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered hiberix without the diluent; Administered hiberix without the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) (batch number 335N9, expiry date unknown) for prophylaxis.   On 26th April 2022, the patient received Hiberix. On 26th April 2022, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  Registered nurse reported that, there were 3 vaccines that were administered hiberix without the diluent. She was unaware of how these vaccines were reconstituted so were unable to give any information. The reporter consented to follow up. Additional Supportive Information:  The patient received Hiberix without the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022075751:Same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered hiberix without the diluent; Administered hiberix without the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) (batch number 335N9, expiry date unknown) for prophylaxis.   On 26th April 2022, the patient received Hiberix. On 26th April 2022, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  Registered nurse reported that, there were 3 vaccines that were administered hiberix without the diluent. She was unaware of how these vaccines were reconstituted so were unable to give any information. The reporter consented to follow up. Additional Supportive Information:  The patient received Hiberix without the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076035:Same reporter. US-GLAXOSMITHKLINE-US2022075751:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Mass, Skin warm
Clinical narrative: There's a lump in my; It is warm; This case was reported by a consumer via interactive digital media and described the occurrence of mass in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced mass and skin warm. On an unknown date, the outcome of the mass and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the mass and skin warm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine yesterday (day before reporting) and now there was a lump in his/her and it was warm. The patient asked was that normal. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got vaccinated, still got shingles even with two doses/Suspected vaccination failure; Got shingles, less severe; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingrix, the patient still got shingles. The patient stated that, it was less severe because he/she was vaccinated but know you could still get them even with getting two doses of Shingrix vaccine. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot, had the worst case of Shingles/Suspected vaccination failure; Had the worst case of Shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, unfortunately the patient still got worst case of shingles. The patient stated that, not everyone was immune. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shot and still got shingles, a milder case/Suspected vaccination failure; Shingles, a milder case on forehead n top of head real close to eye; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. The patient was told it was a milder case, the patient had it on left forehead and top of head, real close to eye and said he/she was lucky. The patient stated that, glad you got shingles shot but no guarantee that you could not or would not get shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Made me tired for a day; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and felt tired for a day. The patient stated that no big deal, better than dealing with the pain GlaxoSmithKline said shingles causes. The patient also stated that he/she didn't have time for that. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Had an immediate outbreak after 1st shot; This 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.   In April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine a couple of weeks ago and had an immediate outbreak of Shingles. The patient asked was that normal. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: I got the shingles shot twice this year/Suspected vaccination failure; Shingles in my right eye; I have  shingles is awful, in the forehead; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient received 2 doses of Shingles vaccine in the year of reporting. After receiving Shingles vaccine, the patient got shingles in forehead and in right eye. The patient stated that, he/she had this was awful. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot last year got the shingles/Suspected vaccination failure; Got the Shingles just last week.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient received Shingles vaccine, in 2021, last year from the date of reporting. After receiving Shingles vaccine, the patient still got shingles in last week from the date of reporting. At the time of reporting, the patient was not suffering but stated that, if the doctor had not seen then, she would not be on the antibiotics. The patient stated that, actually her husband saw them first. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine, but got shingles anyway/Suspected vaccination failure; Got shingles anyway; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles anyway. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Sister got the vaccine and then she got shingles; She got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The case was reported by the patient's brother or sister via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles. Then the patient suggested to get the vaccine, but the reporter said no not right now. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Age: 64.0
Sex: M
Vaccine: COVID19, TDAP, VARZOS
Symptoms: Dry skin, Pruritus, White blood cell count, White blood cell count decreased
Clinical narrative: low white blood cell count; Itching whenever his skin gets wet; Dermatologist told he has dry skin; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and COVID-19 VACCINE for prophylaxis.   Concurrent medical conditions included hypertension and atrial fibrillation.   On 8th March 2021, the patient received the 1st dose of Shingrix and the 1st dose of Tdap Vaccine (intramuscular). On an unknown date, the patient received COVID-19 VACCINE. In March 2021, less than 2 weeks after receiving Shingrix and Tdap Vaccine, the patient experienced pruritus and dry skin. On an unknown date, the patient experienced white blood cell count low. The patient was treated with fexofenadine hydrochloride (Allegra), miconazole nitrate (Monistat), hydrocortisone (Hydrocortisone Cream) and antipruritics nos. On an unknown date, the outcome of the pruritus was not recovered/not resolved and the outcome of the dry skin and white blood cell count low were unknown.   It was unknown if the reporter considered the pruritus, dry skin and white blood cell count low to be related to Shingrix and Tdap Vaccine.     Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: This case was reported by the patient. He received his first Shingrix dose and he also had a Tdap vaccination of unknown manufacturer that day. Within one to two weeks he developed itching to his arms, chest and back. The itching occurred only whenever his skin gets wet like when showering, sweating, washing and lasts 45 to 90 minutes.  He received his second Shingrix dose two months after the first, in May 2021. The patient seen a dermatologist and was told that he had dry skin. He saw another dermatologist and was told he did not have dry skin but this dermatologist was unable to determine the cause of the itching. He has treated the itch with hydrocortisone cream, another anti-itching cream, Monistat spray, an unknown anti-itch pill and Allegra. The Allegra helped a little. The patient consulted his pharmacist and was told that he received the Shingrix dose too soon after the COVID-19 vaccination. The Shingrix vaccine was given about 6 weeks after the COVID vaccine. Less than 2 years after vaccination, the patient had low white blood cells. He had nothing else to report. The consent to follow up was given. The patient might follow up with cardiologist. It was unknown if the reporter considered the pruritus, dry skin and white blood cell count low to be related to COVID-19 VACCINE.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: sore throat; body aches, pain; bruising; cough; fatigued; headaches; diarrhea; sign of congestion; second dose,(subcutaneous) area; This case was reported by a other health professional via call center representative and described the occurrence of sore throat in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of urticaria (1st dose received on 28th January 2022 and experienced a welt, fatigue and tiredness, For tolerance of 1st dose ,refer case US2022AMR073549).   On 29th April 2022, the patient received the 2nd dose of Shingrix (subcutaneous). On 29th April 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced sore throat, general body pain, contusion, cough, fatigue, headache, diarrhea and nasal congestion. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sore throat, general body pain, contusion, cough, fatigue, headache, diarrhea, nasal congestion and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the sore throat, general body pain, contusion, cough, fatigue, headache, diarrhea and nasal congestion to be related to Shingrix.  Linked case(s) involving the same patient: US2022AMR073549   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The reporter was physicians assistant. The reporter reported that, a patient was inadvertently administered the second dose of Shingrix in the posterior triceps (subcutaneous) area.  The reporter called in to inquire about any efficacy and/or safety information of a Shingrix subcutaneous injection. The patient experienced pain, bruising fatigued, body aches, cough, sore throat, sign of congestion, diarrhea, and headaches.  The reporter was unable to provide full vaccine details. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported that, a patient was inadvertently administered the second dose of Shingrix in the posterior triceps (subcutaneous) area, which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR073549:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: sore throat; body aches, pain; bruising; cough; fatigued; headaches; diarrhea; sign of congestion; second dose,(subcutaneous) area; This case was reported by a other health professional via call center representative and described the occurrence of sore throat in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of urticaria (1st dose received on 28th January 2022 and experienced a welt, fatigue and tiredness, For tolerance of 1st dose ,refer case US2022AMR073549).   On 29th April 2022, the patient received the 2nd dose of Shingrix (subcutaneous). On 29th April 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced sore throat, general body pain, contusion, cough, fatigue, headache, diarrhea and nasal congestion. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sore throat, general body pain, contusion, cough, fatigue, headache, diarrhea, nasal congestion and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the sore throat, general body pain, contusion, cough, fatigue, headache, diarrhea and nasal congestion to be related to Shingrix.  Linked case(s) involving the same patient: US2022AMR073549   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The reporter was physicians assistant. The reporter reported that, a patient was inadvertently administered the second dose of Shingrix in the posterior triceps (subcutaneous) area.  The reporter called in to inquire about any efficacy and/or safety information of a Shingrix subcutaneous injection. The patient experienced pain, bruising fatigued, body aches, cough, sore throat, sign of congestion, diarrhea, and headaches.  The reporter was unable to provide full vaccine details. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported that, a patient was inadvertently administered the second dose of Shingrix in the posterior triceps (subcutaneous) area, which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR073549:same reporter
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Fever; Shaking; Sore arm; Nausea; Aches and pains; This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2022, less than a day after receiving Shingrix, the patient experienced fever, tremor, pain in arm, nausea and pain. On an unknown date, the outcome of the fever, tremor, pain in arm, nausea and pain were recovered/resolved.   It was unknown if the reporter considered the fever, tremor, pain in arm, nausea and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The case was reported by patient's wife. The patient also had reactions after his Shingrix vaccine.  Soon after he began experiencing fever, shaking, sore arm, nausea, aches and pains.  These symptoms last 2-3 days and then resolved.  The reporter consented to follow up. Additional Supportive Information: The case had been linked to US2022073186,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022073186:Same Reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of on 9/2/2021, hasn't received second; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 04-May-2022 Reporter's comment: Medical Doctor called on behalf of self to inquire about, how to proceed with the 2nd dose of Shingrix. The reporter stated that it had been 9 months since had not receive the 2nd dose. The reporter unable to provide vaccine details. Did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received a dose that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 93JN5, expiry date 27th March 2022) for prophylaxis.   On 4th May 2022, the patient received Shingrix. On 4th May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 4-May-2022 Reporter's comment: Registered nurse reported that the patient received a dose of Shingrix and the dose had expired on 27th March 2022. The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up. Additional Supportive Information: The patient received a  expired dose of Shingrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on Oct 2019, second had not been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019 with batch number 7RK7A and expiry date 26th November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 04-May-2022 Reporter's comment: Pharmacist would like some guidance if a patient received first dose of Shingrix and on the date of reporting, they were planning to give a second dose however, the second shot had not been given at the moment of the call. Consented to follow up by email. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: A small amount cam out of the syringe; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number x2x35, expiry date 12th May 2023) for prophylaxis.   On 4th May 2022, the patient received the 2nd dose of Shingrix. On 4th May 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 04-May-2022 Reporter's Comments:  The reporter stated that, he/she was administering shingrix, and a small amount came out of the syringe where the needle and syringe connect. The reporter asked if he/she needed to repeat the dose. The reporter consented to follow up via postal. Additional Supportive Information:  The small amount of vaccine came out of the syringe during administration, which led to incomplete dose administered.
Age: 67.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient received a dose that had already expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 67-year-old female patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd May 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd May 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-May-2022 Reporter's Comments:  The pharma intern reported on May 4th 2022 that on May 3rd 2022 patient received a dose of Twinrix that had already expired on February 28th 2022. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information:  The patient received an expired dose of Twinrix vaccine, which led to expired vaccine used.
Age: 0.83
Sex: F
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 10 month old was given first shot of Rotarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number K2fm7, expiry date 4th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th May 2022, the patient received the 1st dose of Rotarix lyophilized formulation (oral) 1 ml and Rotarix Oral Applicator Device. On 4th May 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 04-MAY-2022 Reporter's Comment: Nurse practitioner stated that a 10 month old was given their first shot of Rotarix on the day of reporting. The reporter consented to follow up. Additional Supportive Information: The 10 month old patient received Rotarix, which led to inappropriate age at vaccine administration.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient was administrated with only the adjuvant of Shingrix; Patient was administrated with only the adjuvant of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number b257h, expiry date 26th June 2023) for prophylaxis.   On 2nd May 2022, the patient received Shingrix. On 2nd May 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: Medical assistance reported that a patient was administrated with only the adjuvant of Shingrix. No adverse event was reported . The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.42
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 month old baby was administered kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B vaccine (received Hepatitis B vaccine on 23rd November 2021). Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (DTAP VACCINE), POLIOMYELITIS VACCINE INACTIVATED (IPV (INACTIVATED POLIO VACCINE)), HIB VACCINE and VAXELIS.   On 26th April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 26th April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 04-May-2022 Reporter's Comments: Nurse reported a 5 month old baby was administered kinrix. Vaccine history (DTAP,Inactivated Polio vaccine, Hepatitis vaccine, HIB- Merck- Snaofi- Vaxelis) in February 2022 and on 23rd November 2021: Hepatitis B vaccine. The Healthcare professional said that she would call back with patient information and other details as she did not have permission to give it out. The reporter consented to follow up. Additional Supportive Information: The 5 month old patient was administered with Kinrix, which led to inappropriate age at vaccine administration.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Rash
Clinical narrative: muscle soreness/ chills across her upper back; rash on her arm; muscle soreness/ chills across her upper back; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 2nd June 2023) for prophylaxis.   On 18th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced chills, rash and muscle soreness. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the rash and muscle soreness were recovered/resolved.   It was unknown if the reporter considered the chills, rash and muscle soreness to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-May-2022 Reporter's comments: This case was reported by the patient. After receiving Shingrix, the patient experienced muscle soreness and a rash on her arm that has resolved. The patient also experienced chills across her upper back that persist. The patient gave medical disclaimer and referred to the healthcare professional. The patient was provided with medical information phone number for the healthcare professional reference and offered after call survey. The consent to follow up was given.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Hypotension, Pain, Pyrexia
Clinical narrative: felt a little bit dizzy,  I do feel lightheaded; my blood pressure was way down, it fell down to 99/53, has gone as low as 89/54; felt like I was running a fever; sharp pains shooting through my head,; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date) and Shingrix (1st dose received on an unknown date). Concurrent medical conditions included atrial fibrillation and hypertension. Concomitant products included metoprolol, apixaban (Eliquis), lisinopril and flecainide.   On 26th April 2022, the patient received the 2nd dose of Shingrix. On 26th April 2022, less than a day after receiving Shingrix, the patient experienced headache. On an unknown date, the patient experienced dizziness, low blood pressure and fever. On an unknown date, the outcome of the dizziness, fever and headache were recovered/resolved and the outcome of the low blood pressure was not recovered/not resolved.   It was unknown if the reporter considered the dizziness, low blood pressure, fever and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-May-2022 Reporter's comments: This case was reported by the patient. The patient received 2nd dose of Shingrix and in night of 26th April, the patient experienced sharp pains shooting through head which was minor. Less than 2 weeks after vaccination, the patient felt like was running a fever but did not take temperature. The patient felt a little bit dizzy. The patient had been on blood pressure medicines for like 40 years. The patient took blood pressure and blood pressure was way down and the patient thought it would probably in a day or two be fine but it was staying down. The patient talked to the heart doctor and they actually cut one of medications flecainide in half. The blood pressure was staying low and sometimes it goes low fairly fast. The highest it had been since the patient had the Shingrix shot was 129/64. Normally with all medications the patient would stay in the low 120/50. Within 2 hours after taking medication it came down to 107 which usually it was 120 then it fell down to 99/53 and it had gone as low as 89/54.  In the morning of date of reporting, the patient took it at 6:05 and it was 114/54 and the patient still had not taken medicine. At 8:39 it was 108/58. The patient's pulse was where they want it in the 50's low 60's. The oxygen was staying up. The blood pressure always stayed the same previously. At times the patient felt lightheaded. The call center representative unable to ask further questions such as date of birth, MD contact information because call ended abruptly when reporter received an inbound phone call from his doctor's office.
Sex: M
Vaccine: VARZOS
Symptoms: Therapy change
Clinical narrative: felt a little bit dizzy,  I do feel lightheaded; my blood pressure was way down, it fell down to 99/53, has gone as low as 89/54; felt like I was running a fever; sharp pains shooting through my head,; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date) and Shingrix (1st dose received on an unknown date). Concurrent medical conditions included atrial fibrillation and hypertension. Concomitant products included metoprolol, apixaban (Eliquis), lisinopril and flecainide.   On 26th April 2022, the patient received the 2nd dose of Shingrix. On 26th April 2022, less than a day after receiving Shingrix, the patient experienced headache. On an unknown date, the patient experienced dizziness, low blood pressure and fever. On an unknown date, the outcome of the dizziness, fever and headache were recovered/resolved and the outcome of the low blood pressure was not recovered/not resolved.   It was unknown if the reporter considered the dizziness, low blood pressure, fever and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-May-2022 Reporter's comments: This case was reported by the patient. The patient received 2nd dose of Shingrix and in night of 26th April, the patient experienced sharp pains shooting through head which was minor. Less than 2 weeks after vaccination, the patient felt like was running a fever but did not take temperature. The patient felt a little bit dizzy. The patient had been on blood pressure medicines for like 40 years. The patient took blood pressure and blood pressure was way down and the patient thought it would probably in a day or two be fine but it was staying down. The patient talked to the heart doctor and they actually cut one of medications flecainide in half. The blood pressure was staying low and sometimes it goes low fairly fast. The highest it had been since the patient had the Shingrix shot was 129/64. Normally with all medications the patient would stay in the low 120/50. Within 2 hours after taking medication it came down to 107 which usually it was 120 then it fell down to 99/53 and it had gone as low as 89/54.  In the morning of date of reporting, the patient took it at 6:05 and it was 114/54 and the patient still had not taken medicine. At 8:39 it was 108/58. The patient's pulse was where they want it in the 50's low 60's. The oxygen was staying up. The blood pressure always stayed the same previously. At times the patient felt lightheaded. The call center representative unable to ask further questions such as date of birth, MD contact information because call ended abruptly when reporter received an inbound phone call from his doctor's office.
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Kinrix was used as 3th and 4th Dtap IPV series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number h9y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap IPV (2 doses received on an unknwon dates).   On 18th October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 5-May-2022 Reporter's comments: The patient received Kinrix as part of a 3rd dose series of Dtap IPV. Nurse informed that patient was doing a catching up of immunization.  Then Kinrix was planned as 4th dose of Dtap IPV series. The vaccine administration facility was the same as primary reporter. The follow up was not requested. Additional Supportive Information: The patient received Kinrix as part of a 3rd dose series of Dtap IPV, which led to inappropriate schedule of vaccine administered.
Age: 67.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late second dose on  4/25/22; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received HAB (Twinrix adult) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 27th October 2021, batch number DK23D, expiry date 8th February 2022).   On 25th April 2022, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 25th April 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, 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: 5-May-2022 Reporter's comments: The pharmacist inquired how to proceed with the third dose of Twinrix. The patient received late second dose. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Twinrix late than recommended time frame, which led to which led to lengthening of interval between vaccine doses.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Only received the first dose on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose recevied in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The patient was late for the second dose of Shingrix. The consent to follow up was given. The patient only received the first dose. No lot number and expiration date provided. No vaccination date provided. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.