chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were provided as follows: The age at vaccination was not reported. The reporter knew the patient who got shingles even though he/she received Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This case had been linked with case US2021AMR188188, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188188:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel awful; This case was reported by a consumer (Shingrix GSK Chatbot) and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included diabetes.   On 27th August 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient self reported this case. The patient received 2nd dose and felt awful, no serious side effects just the normal ones. The patient know the side effects could last 2 to 3 days. The patient asked if the side effects could last longer as after a week, the patient was still having mild side effects, and asked if was this normal.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Incorrect route of product administration
Clinical narrative: feel awful; This case was reported by a consumer (Shingrix GSK Chatbot) and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included diabetes.   On 27th August 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient self reported this case. The patient received 2nd dose and felt awful, no serious side effects just the normal ones. The patient know the side effects could last 2 to 3 days. The patient asked if the side effects could last longer as after a week, the patient was still having mild side effects, and asked if was this normal.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2021, the patient received the 1st dose of Shingrix. On 2nd September 2021, several hours after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient self reported this case. The patient received Shingrix injection around noon today (day of reporting) and a couple hours later he had soreness on the arm where he received the injection, he still had some soreness (arm soreness, unresolved). The patient asked could he take advil for arm soreness. The patient consented to follow up with his doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccination and now I've had them  / suspected vaccination failure; had them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shingles, one time got the vaccination and now patient had shingles live or six times This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles after being vaccinated / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had shingles after being vaccinated. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Malaise, Vaccine positive rechallenge
Clinical narrative: soreness at injection site; tiredness; didn't feel good; 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.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021AMR151464).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain, tiredness and feeling unwell. The patient was treated with ibuprofen. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain, tiredness and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received 2nd dose, 4 months after 1st dose. The patient experienced soreness at injection site, tiredness and did not feeling good. The patient was treated  with ibuprofen. The patient was feeling good now, soreness was gone. The patient stated that he/she received 2 shingles shot and praying he/she would never get a shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151464:same reporter same patient
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got it and got shingles. / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, 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 case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The reporter stated just another added for a worthless vaccine. The patient got vaccine and got shingles. Just like the people taking the shots now were. The reporter stated nice advertisements to make the rich richer. People were being terrified into taking shots and making their loved ones take them and not caring about side effects because of their fear. The reporter first time got covid, she got it from her face shot if that tells you anything so it was time to wise up and boost your own immune system and stop thinking you need all these shots. The reporter stated you wee just lining rich peoples pockets. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR188396 repored by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: last 24 hours was pretty rough/ feeling absolutely horrible; fever; sweats; This case was reported by a consumer via interactive digital media  and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 31st August 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced feeling unwell, fever and sweating. On an unknown date, the outcome of the feeling unwell, fever and sweating were unknown.   It was unknown if the reporter considered the feeling unwell, fever and sweating to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had second Shingles shot. And although the patient was feeling much better at the time of reporting. The patient reported that the last 24 hours was pretty rough no itching and no sign of shingles or anything like that the patient just went through a period of fever sweats and just plain feeling absolutely horrible. The patient was on the mend now, and the patient agreed to get the shots. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered liquid only portion of Menveo, not mixed with the lyophilized A component; administered liquid only portion of Menveo, not mixed with the lyophilized A component; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the  patient was administered liquid only portion of Menveo, which was not mixed with the lyophilized A component prior to administration, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles shots years ago, got 1st covid shot and got shingles again / suspected vaccination failure; Got shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 62-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got shingles shot years before reporting and told to patient he or she would not ever need them again but did broke out between two shots, but patient have shingles off and on for years. The patient was in hospital with COVID the end of January got shingles in the hospital and patient got first shot and broke out in shingles again. The patient told not to take 2nd shot of COVID. The patient also had shots for shingles, patient do get shingles even after shots but after the COVID was very painful. It was unknown if the reporter considered the vaccination failure and shingles to be related to COVID-19 VACCINE. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This is 1 of 4 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183413:Same reporter US-GLAXOSMITHKLINE-US2021AMR188669:Same reporter. US-GLAXOSMITHKLINE-US2021AMR188679:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn't receive the second shot; This case was reported by a consumer via (Shingrix GSK and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Had them at least twice a year or more since my 20's / Suspected vaccination failure; Had them at least twice a year or more since my 20's; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 case details were reported as follows: The age at vaccination was not reported. The patient had shingles twice a year or more. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This is 1 of 4 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183413:Same reporter US-GLAXOSMITHKLINE-US2021AMR188669:Same reporter. US-GLAXOSMITHKLINE-US2021AMR188669:Same reporter US-GLAXOSMITHKLINE-US2021AMR183413:Same reporter. US-GLAXOSMITHKLINE-US2021AMR188646:Same reporter.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix given to a 9 month old baby by error; Pediarix was 2nd Dtap, Kinrix as 3rd dose in Dtap series; Pediarix was 2nd Dtap, Kinrix as 3rd dose in Dtap series; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number HD7L7, expiry date 31st August 2021) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (1st dose received on 25th January 2021).   On 24th May 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 23rd August 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device and unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of drug administration. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of drug administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Infanrix was the 1st dose in the Dtap series and Pediarix was the 2nd Dtap and also given Kinrix as there 3rd dose in the Dtap series which led to interchange of vaccine products, wrong vaccine administered and inappropriate schedule of drug administration. The patient received Infanrix and Pediarix is within the age recommendations but Kinrix vaccine was given to a 9 month old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Myalgia
Clinical narrative: myalgia; fever; shivering; headache; fatigue; gastrointestinal symptoms; This case was reported by a consumer and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2021 09:30, the patient received the 2nd dose of Shingrix. On 26th August 2021 09:00, 11 hrs 30 min after receiving Shingrix, the patient experienced myalgia, fever, shivering, headache, fatigue and gastrointestinal disorder. On an unknown date, the outcome of the myalgia, fever, shivering, headache, fatigue and gastrointestinal disorder were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, fever, shivering, headache, fatigue and gastrointestinal disorder to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The patient received second dose of Shingrix at 9:30 am and experienced myalgia, fever, headache, shivering, fatigue and gastrointestinal symptoms. All symptoms began around 9:00pm, the same day and were ongoing till the time of reporting. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: myalgia; fever; shivering; headache; fatigue; gastrointestinal symptoms; This case was reported by a consumer and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2021 09:30, the patient received the 2nd dose of Shingrix. On 26th August 2021 09:00, 11 hrs 30 min after receiving Shingrix, the patient experienced myalgia, fever, shivering, headache, fatigue and gastrointestinal disorder. On an unknown date, the outcome of the myalgia, fever, shivering, headache, fatigue and gastrointestinal disorder were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, fever, shivering, headache, fatigue and gastrointestinal disorder to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The patient received second dose of Shingrix at 9:30 am and experienced myalgia, fever, headache, shivering, fatigue and gastrointestinal symptoms. All symptoms began around 9:00pm, the same day and were ongoing till the time of reporting. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: never received their 2nd due to COVID (pandemic); This case was reported by a pharmacist and described the occurrence of social problem in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient never received their 2nd due to COVID pandemic, which led to social problem. No lot or expiration date available because it was administered at a different site. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Never came back for 2nd dose, due to COVID pandemic; This case was reported by a pharmacist via and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient never received 2nd dose of Shingrix due to COVID pandemic, which led to social problem. The reporter consented to follow up. This case was linked with case US2021AMR186082, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186082:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Shingrix to a patient 19 years of age; varicella vaccine was intended to be given; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 19-year-old male patient who received Herpes zoster (Shingrix) (batch number 4n2ab, expiry date 10th February 2023) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix. On 30th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The registered nurse informed that, during the day a nurse practitioner administered Shingrix to a patient 19 years of age when varicella vaccine was intended to be given, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: patient only received a partial dose. (under dose; This case was reported by a pharmacist and described the occurrence of accidental underdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th August 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that during administration the syringe malfunctioned and the patient only received partial dose, which led to accidental underdose. The pharmacist declined to provided patient information, lot number, expiration date, and his location. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hallucination, Headache, Incomplete course of vaccination, Malaise, Retching
Clinical narrative: Did not get the second dose; Hallucinations; Headache; Malaise; Dry heaves; This case was reported by a consumer via call center representative and described the occurrence of hallucination in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number XN443, expiry date 15th May 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 24th June 2020 10:00, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 24th June 2020, 2 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hallucination (serious criteria GSK medically significant), headache, malaise and dry heaves. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the hallucination, headache, malaise and dry heaves were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the hallucination, headache, malaise and dry heaves to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient states she had the Shingrix dose and by noon she experienced headache, malaise, dry heaves, and hallucinations. The patient feels that she was possibly given too large of Shingrix dose and it appeared to be much greater than 0.5 ml in the syringe she was given that day. The patient states she did not get and has no plans to get the Shingrix 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: giving a pediatric dose of Havrix; giving a pediatric dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult female patient who received HAV (Havrix pediatric) for prophylaxis.   On 13th February 2020, the patient received the 1st dose of Havrix pediatric. On 13th February 2020, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details provided were as follows: The age at vaccination was not reported. The health care professional called to report that a pediatric dose of Havrix was administered to an adult which led to underdose and adult use of a child product.  The health care professional did not have the batch number or any additional information.  The reporter consented to follow up. The case has been linked with case US2021183446, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183446:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Injection site rash
Clinical narrative: rash down the arm at the injection site; felt extremely exhausted; extremely cold; This case was reported by a consumer and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash, exhaustion and feeling cold. On an unknown date, the outcome of the injection site rash, exhaustion and feeling cold were unknown.   It was unknown if the reporter considered the injection site rash, exhaustion and feeling cold to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received the first dose of Shingrix and she experienced a rash down the arm at the injection site and was down for about 3 days (felt extremely exhausted, extremely cold). Reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Twinrix back in Feb 2021.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 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.   Previously administered products included Twinrix (received 1st dose in February 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix which led to incomplete course of vaccination. The reporter asked if the patient could get the 2nd dose now or did he/she need to restart, and how to proceed with the 3rd dose. The healthcare professional declined to provide patient information. Reporter consented to follow-up by email.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: that Kinrix was administered to a 6 month old, instead of Pediarix; Kinrix was administered to a 6 month old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, 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 27th August 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The reporter stated that Kinrix was administered to a 6 month old, instead of Pediarix (should have been 3rd dose) which led to wrong vaccine administered and inappropriate age at vaccination. Reporter consented to follow-up by e-mail.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: got her first Shingrix vaccine in 2019 but not the second one due to the pandemic; This case was reported by a consumer and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, did not receive 2nd dose of Shingrix due to pandemic, which led to social problem. The reporter did not consent to follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Palpitations, Rash pustular
Clinical narrative: intermittent palpitations; thinks that patient developed shingles/suspected shingles; Pustules at V3 Dermatome; This case was reported by a physician and described the occurrence of shingles in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiovascular disorder.   On 19th August 2021, the patient received the 1st dose of Shingrix. In August 2021, 36 hrs after receiving Shingrix, the patient experienced shingles and pustular rash. On 19th August 2021, the patient experienced palpitation. On 31st August 2021, the outcome of the shingles, pustular rash and palpitation were recovered/resolved.   It was unknown if the reporter considered the shingles, pustular rash and palpitation to be related to Shingrix.  Additional details were provided as follows: The doctor of medicine (MD) reported that the patient received the 1st dose of Shingrix and 36 hours after the vaccination, she developed pustules at V3 dermatome. The patient had intermittent palpitations, no chest pain or shortness of breath noted. The reporter thought that the patient had developed shingles following 1st dose of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 18 months ago from the date of reporting).   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 details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo vaccine was reconstituted with sterile diluent and administered to a patient; Menveo vaccine was reconstituted with sterile diluent and administered to a patient; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 30th August 2021, the patient received Menveo. On 30th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that Menveo vaccine was reconstituted with sterile diluent and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No more information about lot number, expiration date and patient details was provided. The reporter consented to follow up by email.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose was given to the patient more than 6 months ago; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received more than 6 months ago from the date of reporting).   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 details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The pharmacist did not administered the patient, and did not have information about the 1st dose and about the patient. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Rash papular
Clinical narrative: Mild allergic reaction; Red bumps; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2022) for prophylaxis.   On 19th March 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced allergic reaction, papular rash and pruritus. On an unknown date, the outcome of the allergic reaction, papular rash and pruritus were unknown.   It was unknown if the reporter considered the allergic reaction, papular rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient had experienced a mild allergic reaction of red bumps and itching after Shingrix administration. These were the only symptoms that were mentioned by the patient to the reporter.  Patient had asked the reporter if she should get the second dose. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on Dec-29-2020, had not received second dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th December 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 details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, till the time of reporting, the patient did not receive 2nd dose of Havrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2018171001 and US2020134686, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018171001:same reporter US-GLAXOSMITHKLINE-US2020134686:same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: first and second dose in 2019, outbreak of shingles / suspect Vaccination failure; shingles in eye; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix. In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The patient called on day of reporting to inquire if it was recommended to get a booster for Shingrix. The patient stated she had the first dose of Shingrix in April and second dose in June of 2019. The patient stated she had an outbreak of shingles in her eye last year. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation for herpes zoster was unknown at the time of reporting. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with sterile water.; Shingrix was administered after being reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number BM27F, expiry date 14th November 2022) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix. On 30th August 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The practice manager reported that, the first dose of Shingrix was administered after being reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: powder reconstituted with other diluent; powder reconstituted with other diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA582A, expiry date 30th August 2022) for prophylaxis.   On 31st August 2021, the patient received Menveo. On 31st August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The nurse reported that the powder was reconstituted with other diluent not the one that comes with the Menveo vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Side effects of swelling at injection site; Redness at injection site; Warmth at injection site; Itching at injection site; This case was reported by a consumer and described the occurrence of injection site swelling in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th July 2021, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site itching to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received the 1st dose of Shingrix in left deltoid muscle and next day the patient developed swelling, redness, warmth, and itching at the injection site. The patient experienced these side effects for 5-6 days post vaccination and later they got resolved. The reporter did not give a consent to follow-up with HCP (health care professional), Therefore, contact information to HCP was not collected. The reporter was not given any information from the pharmacy regarding Shingrix, therefore, she does not have lot/exp date and dose. The reporter did not consent to follow up.