chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Pain in extremity, Palpitations
Clinical narrative: Got dizzy; My heart started pounding; Very tired; Very, very sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th May 2022, the patient received the 1st dose of Shingles vaccine. On 6th May 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On 7th May 2022, the patient experienced dizziness, heart pounding and fatigue. On 8th May 2022, the outcome of the pain in arm, dizziness, heart pounding and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, dizziness, heart pounding and fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-May-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got first shot on Friday and had very, very sore arm.  The next day, the patient was cleaning off some porch furniture and got dizzy, and heart started pounding, was very tired. On Sunday, was all good. The patient stated, it was better than getting Shingles for sure. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: ached really badly; fever about 36 hours; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date in last year and experienced pain and fever, refer link case US2022AMR076844).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 36 hrs after receiving Shingrix, the patient experienced pain and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and fever were unknown.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR076844   Additional Information: GSK Receipt Date: 8-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient received 2nd dose in last year 2021 and have not gotten shingles. The patient ached really badly and had a fever about 36 hours after getting the vaccines, but that was it. The patient stated that if you had chickenpox, you could get shingles. The patient decided to take chances with the vaccine. The patient knew people who were not vaccinated, got shingles and still suffer from horrible nerve pain.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076844:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm is pretty sore; feel drained; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and exhaustion. On an unknown date, the outcome of the pain in arm and exhaustion were unknown.   It was unknown if the reporter considered the pain in arm and exhaustion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media.  The patient got the shingles first Shingles shot on the day before the date of reporting and felt drained. The patient's arm was pretty sore. The patient asked if anyone else had them too or not.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Sore arm where the shot was administered; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporter's comments: The patient said just a sore arm where the shot of Shingles vaccine was administered.  The event was recovered after a few days.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Off label use, Pain, Skin discolouration
Clinical narrative: I had shingles, my doctor gave me a shot; This case was reported by a consumer via interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   Additional Information: GSK Receipt Date: 09-MAY-2022 Reporter's comment: The case was self reported by the patient via interactive digital media. The patient had shingles and doctor said he had only seen one case worse than him/her. The reporter reported that flesh turned black and doctor gave a dose of Shingles vaccine. At that time patient was getting ready for back surgery. The patient reported that Shingles shot helped to ease terrible pain, so patient was glad that he/she got shingles. The patient asked he/she was the only one to ever make that statement. Additional Supportive Information: The patient had shingles and was administered Shingles vaccine by the doctor, which led to off label use. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingle; This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: In 2018, within a few days after receiving Shingrix, the patient within the reporter's clinic experienced a case of shingles. The reporter did not consent to follow up. Additional supportive information: This case had been linked with case US2022AMR077357, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR077357:Same reporter. Patient 2 of 2.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingle; This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: In 2018, within a few days after receiving Shingrix, the patient within the reporter's clinic experienced a case of shingles. The reporter did not consent to follow up. Additional supportive information: This case had been linked with case US2022AMR077334, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR077334:Same reporter. Patient 1 of 2.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nervousness, Vaccination failure
Clinical narrative: Had both shots, 2 yrs later had one mild case/suspected vaccination failure; Mild case, happens when I'm run down and nervous; Nervous; 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.   The patient's past medical history included shingles (had it bad for three years).   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nervous. On an unknown date, the outcome of the vaccination failure, shingles and nervous were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nervous to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-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 did not have it for two years then just had one mild case of shingles. The patient stated that, it happened when he/she was run down and nervous. The patient was currently selling his/her home. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory test confirming shingles was unknown at the time of reporting. Follow up would not be possible as no contact details were provided. This case had been linked with case US2022AMR077292, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash around the shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine 7 days ago from the date of reporting and experienced rash around the shingles vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: way worse without the shots I have noticed/suspected vaccination failure; way worse without the shots I have noticed; 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: 11-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported it would have way worse without the shots, he/she had noticed. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Malaise, Paraesthesia
Clinical narrative: Feeling a little tingling; I'm about to get sick, but not bad; This case was reported by a consumer via interactive digital media and described the occurrence of tingling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On 10th May 2022, the patient received Shingles vaccine and COVID-19 VACCINE. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced tingling and malaise. On an unknown date, the outcome of the tingling and malaise were unknown.   It was unknown if the reporter considered the tingling and malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles vaccine on the day before the date of reporting. The patient had Covid booster dose on same time. In May 2022, less than a week after receiving covid 19 vaccine, the patient felt a little tingling like was about to get sick, but not bad. The patient asked if anyone had any side effects and if so how long did it last. It was unknown if the reporter considered the tingling and malaise to be related to COVID-19 VACCINE.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pruritus, Swelling, Urticaria
Clinical narrative: Shot given subq in back if right arm instead of IM.  Hive and itching started just past 2 hours after shot. Redness itching swelling has continued for 2nd day after shot.  Started on steroids, antihistamines, topical cortisone and keflex as redness is moving into elbow joint.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had a vaccine, now has shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years 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: 10-May-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient had a vaccine a few years ago and now had shingles but had not broken out on the outside. The reporter thought he had broken out on the inside. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.  The case was linked with case US2022AMR077472 and US2022AMR077476, reported by same reporter for herself.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR077472:Same reporter US-GLAXOSMITHKLINE-US2022AMR077476:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine, got shingles/suspected vaccination failure; 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: 11-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingle vaccine and still got the shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the vaccine, came down with shingles/suspected vaccination failure; shingles; painful; 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. In May 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-May-22 Reporter's comment: The case was received from the patient via interactive digital media. The patient self-reported this case. The patient stated that although he/she had the vaccine and came down with shingles last week. It was the most painful experienced he/she had ever endured. The patient reported that they said that when you took the vaccine, the break out was not as bad. The patient stated that if that's the case, the patient was glad to had the vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding the completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I am WELL PAST the second dose for Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2021).   On an unknown date, the patient received 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: 11-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media. The patient was well past the second dose of Shingrix. The patient stated that, he/she never received a reminder and enquired if he/she should bother. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm is hurting really bad; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles shot on the day before the reporting. The patient's arm was hurting really bad. The patient was told to put an ice pack on it. The patient asked was that correct, the patient would have thought heat. Additional supportive information: From the narrative it seems that the patient had not used icepack but he/she was confirming if it was correct hence it was not coded as treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Muscle fatigue, Pyrexia
Clinical narrative: 100.0 fever; Chills; Extreme muscle fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever, chills and muscle fatigue. On an unknown date, the outcome of the fever, chills and muscle fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills and muscle fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-MAY-2022 Reporter's Comments:  The case was reported via interactive digital media. At the time of reporting the patient experiencing fever(100), chill and extreme muscle fatigue after receiving shingles vaccine. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Tinnitus, Vaccination failure
Clinical narrative: shingrix vaccine 90% effective. I have shingles/suspected vaccination failure; shingrix vaccine 90% effective. I have shingles; I have tinnitus; 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.   On an unknown date, the patient received Shingrix. On 12th May 2022, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and tinnitus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and tinnitus to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. Eighteen months prior to the reporting, the patient paid 200 dollars for Shingrix vaccine. On the day of reporting, the patient had shingles and tinnitus. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient received 2 vials of liquid adjuvant; Patient received 2 vials of liquid adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number 24LA3, expiry date July 2023) for prophylaxis.   On 11th May 2022, the patient received Shingrix. On 11th 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: 11-MAY-2022 Reporters comment: The patient was administered 2 vials of liquid adjuvant instead of 1 adjuvant and 1 powder. No side effects were reported at the time of reporting. Additional supportive information: The patient was administered 2 vials of liquid adjuvant instead of 1 adjuvant and 1 powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Red splotches, shoulder to elbow; This case was reported by a consumer via interactive digital media and described the occurrence of red blotches in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced red blotches. On an unknown date, the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the red blotches to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-MAY-2022 Reporter's Comments: The case was reported by patient via interactive digital media. The patient received 1st dose of Shingrix about 24 hours ago from the time of reporting. The patient arm was red splotches about halfway from shoulder to elbow. The patient asked whether he/she should be worried about reaction. No other information was provided. Additional Supportive Information: Follow up would not be possible since no contact details provided.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Cough
Clinical narrative: bad cough, still lingering; This case was reported by a consumer via call center representative and described the occurrence of cough in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 1st dose of Shingrix. In March 2022, 1 day after receiving Shingrix, the patient experienced cough. On an unknown date, the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the cough to be related to Shingrix.     Additional Information: GSK receipt date: 12-MAY-2022 Reporter's comment: The patient received 1st dose of Shingrix in mid-March and day after he/she started with a bad cough and it was still lingering.  The patient was wondering whether anyone else had experienced such a reaction.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: YEAR OVERDUE FOR SECOND SHOT; This case was reported by a other health professional via interactive digital media 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 on an unknown date).   On an unknown date, the patient received 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: 13-MAY-2022 Reporter's Comments: This case was reported by a other health professional via interactive digital media. The patient had about a year overdue for his 2nd dose of Shingrix. The reporter asked did the patient need to restart the entire series. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot in June 2018 but never got the 2nd.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in June 2018).   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: 13-MAY-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient never got the second. The patient asked should he/she go ahead now and get the second shot, start the series over, or just leave well enough alone. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 18-oct-2019 and then the 2nd one 12-apr-2022.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18October 2019, 0.5 ml intramuscularly).   On 12th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th April 2022, unknown after receiving Shingrix, 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.       Additional Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The pharmacist stating that she had a patient get her first Shingrix vaccine and received 2nd dose late.  The pharmacist did not have any additional details about the vaccine in terms of lot or expiration. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose late which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pyrexia
Clinical narrative: Redness in arm; Bruise from elbow to shoulder; Fever; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2022, the patient received the 1st dose of Shingrix. On 23rd April 2022, 1 days after receiving Shingrix, the patient experienced erythema of extremities, contusion and fever. On an unknown date, the outcome of the erythema of extremities, contusion and fever were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, contusion and fever to be related to Shingrix.     Additional Information: GSK receipt date: 11-May-2022 Reporter's comment: The patient self-reported this case. Member of public reported that was administered with a dose of Shingrix on her left arm and 1 day after vaccination, the patient developed redness in her arm, bruise from elbow to shoulder and fever.  These were lasted for only 10 days. The patient had no more symptoms. No LOT number and expiration date were provided. Consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Only the diluent was administered to patient; Only the diluent was administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 4KK43, expiry date 26th August 2023) for prophylaxis.   On 10th May 2022, the patient received Shingrix. On 10th 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: 11-MAY-2022 Reporter's comment:  The health care professional reported that only the Shingrix diluent was administered to patient.  The health care professional could not locate lot number and expiry date for the diluent.  The antigen lot was reported. No side effects were reported. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. Additional supportive information: Only the Shingrix diluent was administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was administered only the liquid component; Patient was administered only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA603A, expiry date 30th September 2022) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, 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: 11-MAY-2022 Reporter's comment:  The health care professional reported a patient was administered only the liquid component of the Menveo vaccine. Consent to follow-up was provided by phone or email. Additional supportive information: Only the liquid component of the Menveo was administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise
Clinical narrative: feel fatigue; feel  malaise; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2022, the patient received the 1st dose of Shingrix. On 11th May 2022, 1 days after receiving Shingrix, the patient experienced fatigue and malaise. On an unknown date, the outcome of the fatigue and malaise were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and malaise to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-May-2022 Reporter's comments: The patient received Shingrix and following day after vaccination he began to feel fatigue and malaise. The symptoms have yet to resolve as of today. The reporter provided information as per content on side effects. The patient referred to the healthcare professional. The reporter declined to provide full patient demographics. The reporter did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the adjuvant portion of shingrix, not the antigen; administered only the adjuvant portion of shingrix, not the antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 4NX5J, expiry date 9th June 2023) for prophylaxis.   On 13th April 2022, the patient received the 1st dose of Shingrix. On 13th April 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: 12-MAY-2022 Reporter's Comment: Health care professional (HCP) reported a patient was administered only the adjuvant portion of Shingrix and not the antigen. The Vaccine Administration Facility is 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.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on the front of body; This case was reported by a physician via sales rep and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-May-2022 Reporter's comments: Two weeks after receiving a dose of Shingrix, the patient developed a rash on the front of his body. The reporter did not know if dose was first or second dose of Shingrix. The consent to follow up was given.
Sex: U
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: a dose of rotarix was given that expired on 05/02/2022; This 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 Rota (Rotarix lyophilized formulation) (batch number unknown, expiry date 2nd May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 12th May 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 12th May 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 12-May-2022 Reporter's comment: Practice manager reported that on the date of reporting, a dose of Rotarix was given that was already expired on 2nd May 2022. The reporter unable to provide any additional adverse event information at this time. The reporter gave consent for safety to follow-up. Additional Supportive Information: The patient received an expired dose of Rotarix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in January 2020, had not yet received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   On an unknown date, the patient received 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: 13-MAY-2022 Reporters comment: The patient self-reported the case. She received her first dose of Shingrix in January 2020 and had not yet received her second dose of Shingrix at the time of the call.   The patient did not wish to consent for follow up The patient provided limited information Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: vaccines excursion, administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th May 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, 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: 13-MAY-2022 Reporters comment: Vaccine coordinator reported the vaccines excursion that was previous reported to be discarded, was administered to the patient in right thigh. The reporter did not consent to follow-up. Additional supportive information: The vaccine excursion that was previous reported to be discarded, was administered to the patient, which led to incorrect storage of drug. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022078360:Same reporter US-GLAXOSMITHKLINE-US2022078362:Same reporter
Age: 38.0
Sex: M
Vaccine: HEPAB
Symptoms: Product storage error
Clinical narrative: vaccines excursion, administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 38-year-old male 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.   On 12th May 2022, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, 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: 13-MAY-2022 Reporters comment: Vaccine coordinator reported the vaccine excursion that was previous reported to be discarded, was administered to the patient. The reporter did not consent to follow-up. Additional supportive information: The vaccine excursion that was previous reported to be discarded, was administered to the patient, which led to incorrect storage of drug. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022078361:Same reporter US-GLAXOSMITHKLINE-US2022078360:Same reporter
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 3th dose was not administered yet; Patient receiving 1st dose on 26-jun-2003 and 2nd dose on 08-aug-2003; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) 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, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 26th June 2003).   On 8th August 2003, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 8th August 2003, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination 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: 13-MAY-2022 Reporters comment: The patient was 45 years old at the time of reporting. The patient received 2nd dose of Twinrix late and 3rd dose was not administered till the time of reporting.  Patient wanted to remain anonymous, only information the pharmacist provided was that was a female and her age. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule and till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete vaccination schedule.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the 1st dose on 30-May-2021 and received 2nd dose on 01-Mar-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th May 2021).   On 1st March 2022, the patient received the 2nd dose of Shingrix. On 1st March 2022, unknown after receiving Shingrix, 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.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient received 2nd dose of Shingrix late. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.