chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: was given a dose of Kinrix as well as Infanrix in the same visit; was given a dose of Kinrix as well as Infanrix in the same visit.; This case was reported by a nurse via sales rep and described the occurrence of overdose in a 5-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the overdose and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by the patient. The patient was given both a single dose of Kinrix as well as Infanrix in the same visit, which led to overdose and inappropriate schedule of vaccine administered. Consent to follow up granted.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid portion; received only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a adolescent female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMCA602A, expiry date 31st August 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was around 16 years of age. The patient might have received only the liquid portion of Menveo, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up. This case was 1 of 3 case reported by the reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021238417:same reporter US-GLAXOSMITHKLINE-US2021AMR238865:same reporter
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid portion; received only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adolescent female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMCA602A, expiry date 31st August 2022) for prophylaxis.   On 9th November 2021, 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 reported as follows: The age at vaccination was not reported. The registered nurse reported that patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case has been linked with US2021AMR238864, US2021238417, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR238864:same reporter US-GLAXOSMITHKLINE-US2021238417:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient stated that, he/she took a single vaccine and about 2 weeks later, had a stroke. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 67-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (older shingles shot was received at 62).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported but the pateint was around 65 years. The patinet took the newer shot of shingles and had shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after first; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient recived the first dose and developed Shingles. The patient enquired if he/she could get another dose after developing shingles after the first dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot in 2019, do they need to start over ?; 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 vaccine (1st dose received on an unknown date 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired do they need to start over or just get the 2nd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose March of 2020, 2nd dose 18 months after; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received in March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 2nd dose later than the recommended time frame, which led to lengthening of the  vaccine schedule. The patient inquired so he/she consider the the dose or get the 3rd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: broke out in hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. In August 2021, 12 hrs after receiving Shingrix, the patient experienced hives. The patient was treated with prednisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. At the end of august this year the patient received the 1st shot of Shingrix and broke out in hives 12 hours later. The event had lasted for 3 days .  The patient was prescribed prednisone which helped minimally. On the 3rd day the patient took Benadryl which turned the tide.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Nausea
Clinical narrative: horrible headache; chills; nausea; up for 3 hours; This case was reported by a consumer via other manufacturer and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2021, the patient received the 2nd dose of Shingrix. In November 2021, less than a day after receiving Shingrix, the patient experienced headache, chills, nausea and difficulty sleeping. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the chills and nausea were unknown and the outcome of the difficulty sleeping was recovered/resolved.   It was unknown if the reporter considered the headache, chills, nausea and difficulty sleeping to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's daughter. The age at vaccination was not reported. The reporter stated that her mother received the vaccine and woke up at midnight with a horrible headache, chills, and nausea. The patient was up for 3 hours because of these symptoms.  The patient had a headache the next day as well after vaccination.  The reporter stated that her mother lived in and got the vaccine at a pharmacy.  There was no consent to contact the patient. No Health Care Professional information was provided. No Product quality complaint. No further information.
Sex: U
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: 7 years 8 months received only 4 doses in the Dtap series.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 7-year-old patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included Dtap (received 4 dose of Dtap).   On an unknown date, the patient received the 5th dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, 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 patient 7 years 8 months received only 4 doses in the Dtap series. Till  the time of reporting, the patient did not received 5th dose of Dtap, which led to incomplete course of vaccination. The reporter wanted to know how to proceed with Dtap series since patient was to old for the Infanrix and to young for the Boostrix. According to the CDC catch up series patient would be receiving the Boostrix as the 5th dose dose in the Dtap series. Patient had not received the Boostrix before the call was placed with Medical Information. The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: administered 3rd dose of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 99E53, expiry date 9th April 2023) for prophylaxis.   Previously administered products included Shingrix (First dose was administered on 14th June 2021) and Shingrix (Second dose was administered on 22nd September 2021).   On 15th November 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 15th November 2021, an unknown time after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The reporter administered 3rd dose of Shingrix to the patient, which led to extra dose administered. Consent to follow up was granted. VAERS details updated.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Product administration error, Product storage error, Somnolence
Clinical narrative: pain at injection site; Arm soreness / pain and sore left arm; was sleepy from the soreness; was reconstituted and left out at room temperature for 1 hour then administered.; was reconstituted and left out at room temperature for 1 hour then administered; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2021, the patient received the 1st dose of Shingrix. On 15th November 2021, unknown after receiving Shingrix, the patient experienced incorrect storage of drug and product administration error. On an unknown date, the patient experienced injection site pain, pain in arm and sleepiness. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the sleepiness, incorrect storage of drug and product administration error were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm and sleepiness to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case who was also a Pharmacologist. The patient received the first dose of Shingrix in the left arm. Before administration of the first dose, the vaccine was reconstituted and drawn up into a syringe but left out in syringe at room temperature (about 74 Fahrenheit) for 1 hour then administered, which led to incorrect storage of drug and product administration error. The patient experiencing pain at the injection site and arm soreness that lasted approximately 2 to 3 days. It was unknown if symptoms have resolved.  Limited demographics provided. Did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021236254:same reporter - FU1 - deleted.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2 years ago, not yet received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received 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 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. The consent to follow-up was granted.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blister, Petechiae, Pruritus, Rash
Clinical narrative: rashes; welts; blisters; Pin spots; itchy spots on hands, upper thigh and back of leg, gradually spread more; stomach pains; This case was reported by a consumer via call center representative and described the occurrence of localized itching in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9435L, expiry date 8th April 2023) for prophylaxis.   Concurrent medical conditions included meat allergy (had alpha-gal syndrome) and dairy intolerance (Dairy is a trigger for Alpha -gal Syndrome.).   On 28th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2021, 1 days after receiving Shingrix, the patient experienced stomach pain. On 30th October 2021, the patient experienced localized itching. On an unknown date, the patient experienced rash, welts, blister and petechia. On 4th November 2021, the outcome of the stomach pain was recovered/resolved. On an unknown date, the outcome of the localized itching, blister and petechia were not recovered/not resolved and the outcome of the rash and welts were unknown.   It was unknown if the reporter considered the localized itching, stomach pain, rash and petechia to be related to Shingrix.The reporter considered the welts and blister to be possibly related to Shingrix.  Additional details provided were as follows: The case was reported by patient and follow up was by pharmacist. The patient received first dose of Shingrix in the Left arm and about a day later she experienced stomach pains that lasted about a week then it was resolved. The patient also experienced itchy spots on both of her hands, the upper thigh of one leg and the back of the leg of the other leg. The patient also reported the itchy spots started about 2 days after the Shingrix vaccine and had gradually spread more and more. The itchy spots are related to the Alpha-gal Syndrome she contracted about 3 years ago. The itchy spots were manageable but have not resolved. The patient also reported that she had eaten food in the past 2 weeks that contains dairy which might be added to the itchy spots. Dairy is a trigger for Alpha -gal Syndrome. The pharmacist mentioned and the patient believed that the Shingrix vaccine caused welts and blisters. The patient also experienced rashes, welts and blisters. The patient currently had pin spots and blisters at the time of reporting. The pharmacist initially called in to inquire about any milk based protein or meat (alpha gal) in Shingrix. The reporter did not gave permission to contact Health care professional.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: rashes; welts; blisters; Pin spots; itchy spots on hands, upper thigh and back of leg, gradually spread more; stomach pains; This case was reported by a consumer via call center representative and described the occurrence of localized itching in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9435L, expiry date 8th April 2023) for prophylaxis.   Concurrent medical conditions included meat allergy (had alpha-gal syndrome) and dairy intolerance (Dairy is a trigger for Alpha -gal Syndrome.).   On 28th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2021, 1 days after receiving Shingrix, the patient experienced stomach pain. On 30th October 2021, the patient experienced localized itching. On an unknown date, the patient experienced rash, welts, blister and petechia. On 4th November 2021, the outcome of the stomach pain was recovered/resolved. On an unknown date, the outcome of the localized itching, blister and petechia were not recovered/not resolved and the outcome of the rash and welts were unknown.   It was unknown if the reporter considered the localized itching, stomach pain, rash and petechia to be related to Shingrix.The reporter considered the welts and blister to be possibly related to Shingrix.  Additional details provided were as follows: The case was reported by patient and follow up was by pharmacist. The patient received first dose of Shingrix in the Left arm and about a day later she experienced stomach pains that lasted about a week then it was resolved. The patient also experienced itchy spots on both of her hands, the upper thigh of one leg and the back of the leg of the other leg. The patient also reported the itchy spots started about 2 days after the Shingrix vaccine and had gradually spread more and more. The itchy spots are related to the Alpha-gal Syndrome she contracted about 3 years ago. The itchy spots were manageable but have not resolved. The patient also reported that she had eaten food in the past 2 weeks that contains dairy which might be added to the itchy spots. Dairy is a trigger for Alpha -gal Syndrome. The pharmacist mentioned and the patient believed that the Shingrix vaccine caused welts and blisters. The patient also experienced rashes, welts and blisters. The patient currently had pin spots and blisters at the time of reporting. The pharmacist initially called in to inquire about any milk based protein or meat (alpha gal) in Shingrix. The reporter did not gave permission to contact Health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose years ago, has not received her 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a few 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 reporter was the patient. 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. The reporter did not consent to follow up.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with sterile water; reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 2-year-old male patient who received Hib (Hiberix) (batch number 5EP3B, expiry date 7th January 2023) for prophylaxis.   On 11th November 2021, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, 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 provided were as follows: The age at vaccination was not reported. The patient received Hiberix reconstituted with sterile water instead of the diluent portion provided by GSK (GlaxoSmithKline), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Health care professional provided limited information about patient. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyskinesia, Musculoskeletal stiffness
Clinical narrative: Stiff left arm; jerking movement in left arm; This case was reported by a pharmacist via call center representative and described the occurrence of limbs stiffness in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 44DX9, expiry date 28th October 2022) for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Shingrix. On 14th July 2021, less than a day after receiving Shingrix, the patient experienced limbs stiffness and jerkiness. On 17th November 2021, the outcome of the limbs stiffness and jerkiness were recovered/resolved.   It was unknown if the reporter considered the limbs stiffness and jerkiness to be related to Shingrix.   Additional details were reported as follows: This case was reported by the pharmacist. The pharmacist reported patient experienced stiff and jerking movements in left arm after administration of Shingrix vaccine that resolved once patient went to bed. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st dose on 09/12/2019 and 2nd dose on 09/16/2021; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 16th September 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time 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 details were reported as follows; This case was reported by the pharmacist. The patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose to an adult patient; pediatric dose given to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 20-year-old male patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 21st January 2024) for prophylaxis.   On 12th November 2021, the patient received Engerix B pediatric. On 12th November 2021, unknown after receiving Engerix B 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 were reported as follows:  The age at vaccination was not reported. The Nurse called to report that an adult patient had been given a pediatric dose which led to underdose and adult use of a child product. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, HEP, HEPA, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: vaccines were administered after temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HAV (Havrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2021, the patient received Engerix B, Engerix B Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Havrix, Menveo, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Havrix, Menveo, Pediarix and Pediarix 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 details were provided as follows: The age at vaccination was not reported. The physician reported that, had a freezing temperature excursion for their vaccines back in September 2021. These vaccines were administered after this excursion but they had no details at the moment about the patients or the vaccines. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Gait inability, Muscle spasms, Pain
Clinical narrative: Chills; Body aches/ Pain; Vomiting; Diarrhea; cramping; arm pain/ leg pain; leg pain, could not walk; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) (batch number 4c493, expiry date 20th March 2023) for prophylaxis.   Previously administered products included Flu vaccine (received dose on an unknown date), Moderna (received 3 doses on unknown dates) and Zostavax (received dose on an unknown date).   On 6th November 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In November 2021, less than a day after receiving Shingrix, the patient experienced chills, general body pain, vomiting, diarrhea, cramp, pain in arm and unable to walk. On 7th November 2021 16:00, the outcome of the chills, general body pain, vomiting, diarrhea, cramp, pain in arm and unable to walk were recovered/resolved.   It was unknown if the reporter considered the chills, general body pain, vomiting, diarrhea, cramp, pain in arm and unable to walk to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received her 1st dose of Shingrix intramuscularly into her left deltoid at her pharmacy at around 12-1pm in the afternoon.  At 2am the next morning, she woke up with chills, body aches, vomiting, diarrhea, and cramping.  She also reported she experienced arm pain and leg pain that was so bad she could not walk.  By 4pm on 7th November 2021, she reported that all of these symptoms had resolved. The caller reported her reactions to her PCP and her doctor told her she should not get the 2nd dose of the Shingrix. The caller reported that her past vaccination history (dates unknown) included Zostavax, 3 doses of Moderna, and the flu vaccine and she has never had any reactions like she experienced after taking the initial Shingrix vaccine. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Chills; Body aches/ Pain; Vomiting; Diarrhea; cramping; arm pain/ leg pain; leg pain, could not walk; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) (batch number 4c493, expiry date 20th March 2023) for prophylaxis.   Previously administered products included Flu vaccine (received dose on an unknown date), Moderna (received 3 doses on unknown dates) and Zostavax (received dose on an unknown date).   On 6th November 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In November 2021, less than a day after receiving Shingrix, the patient experienced chills, general body pain, vomiting, diarrhea, cramp, pain in arm and unable to walk. On 7th November 2021 16:00, the outcome of the chills, general body pain, vomiting, diarrhea, cramp, pain in arm and unable to walk were recovered/resolved.   It was unknown if the reporter considered the chills, general body pain, vomiting, diarrhea, cramp, pain in arm and unable to walk to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received her 1st dose of Shingrix intramuscularly into her left deltoid at her pharmacy at around 12-1pm in the afternoon.  At 2am the next morning, she woke up with chills, body aches, vomiting, diarrhea, and cramping.  She also reported she experienced arm pain and leg pain that was so bad she could not walk.  By 4pm on 7th November 2021, she reported that all of these symptoms had resolved. The caller reported her reactions to her PCP and her doctor told her she should not get the 2nd dose of the Shingrix. The caller reported that her past vaccination history (dates unknown) included Zostavax, 3 doses of Moderna, and the flu vaccine and she has never had any reactions like she experienced after taking the initial Shingrix vaccine. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Error storage for Engerix-B  given to a 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 male patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   On 4th November 2021, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The practice manager called to report that Engerix-B  was administered to patient after a temperature excursion, which led to incorrect storage of drug. This lot number was exposed to a lowest temperature of 18 degree Fahrenheit for more than 30 days, vaccines are not longer viable. The reporter consented to follow up. This case was linked with case US2021237518, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021237518:Same reporter. Pt 2/2
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Error storage for Engerix-B given to a 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 female patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   On 27th October 2021, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The practice manager called to report that Engerix-B was administered to patient after a temperature excursion, which led to incorrect storage of drug. This lot number was exposed to a lowest temperature of 18 degree Fahrenheit for more than 30 days, vaccines are not longer viable. The reporter consented to follow up. This case was linked with case US2021237516, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021237516:Same reporter. Pt 1/2
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix in 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2018).   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 reporter wanted to get 2nd dose of Shingrix. The patient did not receive 2nd dose till the time of reporting which led to incomplete course of vaccination. The health care professional provided limited information regarding patient's demographic details and vaccines lot number and expiration date since the patient received 1st dose of Shingrix at another facility.  The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 month old patient receiving a dose of HAVRIX; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received HAV (Havrix) (batch number 2JD3Y, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 17th November 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Havrix vaccine, which led to inappropriate age at vaccine administration. No further information was reported. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: 1st dose on 2020, did not receive 2nd dose due to COVID pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles on 28th July 2020) and pruritus (had itching from the inside). Previously administered products included Flu vaccine (received flu vaccine on 22nd September 2020), Zostavax (received the original Shingles vaccine years ago) and Shingrix (recived 1st dose on 22nd September 2020, in an unknown arm).   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 patient did not receive 2nd dose of Shingrix due to COVID pandemic, which led to social problem.  The patient received the original Shingles vaccine years ago (Zostavax). The patient came down with the Shingles disease on 28th July 2020. The patient did not have a rash or blisters, but  he itched from the inside. The patient received Shingrix 1st dose and flu vaccine at the same time on an unknown arm. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 2 doses in 2019 and a third dose on 2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019) and Shingrix (received 2nd dose in 2019).   On 17th November 2021, the patient received the 3rd dose of Shingrix. On 17th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The medical assistant reported that, the patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose on 21Jul2019, it is unclear if a 2nd dose was administered.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st July 2019, batch number 5JX9Z, ).   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. The medical assistant did not have record of the expiration date of vaccine. The second dose was not administered at same facility and it was unclear if a second dose was ever administered.  The patient might have received shingrix out of state, records had been requested and were pending. The reporter consented to follow up.. This case was linked with case US2021238418, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021238418:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose on 21Jul2019, it is unclear if a 2nd dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st July 2019, batch number 5JX9Z).   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. The medical assistant did not have record of the expiration date of vaccine. The second dose was not administered at same facility and it was unclear if a second dose was ever administered.  The patient might have received 2nd dose out of state, records had been requested and were pending. The reporter consented to follow up. This case was linked with case US2021238416, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021238416:same reporter
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid portion; received only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMCA602A, expiry date 31st August 2022) for prophylaxis.   On 9th November 2021, the patient received Menveo. On 9th November 2021, 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 vaccinaton was not reported. The patient might received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021AMR238864 and US2021AMR238865, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR238864:same reporter US-GLAXOSMITHKLINE-US2021AMR238865:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 4 years ago, didn´t received 2nd dose; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix four 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 provided were as follows: Age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The health care professional did not provide any information about vaccination date or patient. The patient was not interested in having a conversation, it only required information about revaccination. The reporter denied to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix 8 months ago / not received the second dose yet.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of 1st dose 8 months ago in unknown arm intramuscularly).   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 provided were as follows: The case was reported by patient herself. Age at vaccination was not applicable. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. No lot number or expiration date was known. Caller declined to provide health care professional information. The reporter did not consent to follow-up.